On 5 September 2025, the World Health Organisation (WHO) announced that it has updated its Model List of Essential Medicines (EML) to include pembrolizumab (including “quality assured biosimilars”) as a first-line monotherapy for metastatic cervical cancer, metastatic colorectal cancer, and metastatic non-small cell lung cancer (NSCLC).  Atezolizumab and cemiplimab (including “quality assured biosimilars”) are listed as therapeutic alternatives to pembrolizumab for metastatic NSCLC.

The WHO Model Lists are updated every two years and are intended as a guide for countries or regional authorities to adopt or adapt in accordance with local priorities and treatment guidelines for the development and updating of national essential medicines lists.  Essential medicines are those considered to satisfy the priority health care needs of a population.

Amongst the biopharmaceuticals added to the Model List this year, ustekinumab and adalimumab (with certolizumab pegol, etanercept and infliximab as therapeutic alternatives) were also added to a complementary list (medicines for which specialised monitoring, diagnostics or care are required) for the treatment of adults and children with moderate-to-severe psoriasis.  Emicizumab has been included on the Model List for Haemophilia A.

MSD’s Keytruda® (pembrolizumab) has been approved in multiple jurisdictions for multiple cancer-related indications.  In August 2025, Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay, under the name Pembrolizumab Bioéticos.  A number of pembrolizumab biosimilars are currently in clinical trials, including those of Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Shanghai Henlius, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.

No biosimilars to Roche’s Tecentriq® (atezolizumab) or Regeneron and Sanofi’s Libtayo® (cemiplimab) have been approved to date.

On 4 September 2025, Celltrion announced that it has launched Steqeyma® (ustekinumab) and Omlyclo® (omalizumab) in Australia, biosimilars to J&J/Janssen’s Stelara® and Novartis’ Xolair®, respectively.  On 1 August 2025, Arrotex announced its strategic licensing agreement with Celltrion for the Australian commercialisation of Celltrion’s ustekinumab and omalizumab biosimilars.

The Arrotex announcement came on the same day that Steqeyma® became the first ustekinumab biosimilar to be PBS-listed (1 August 2025).  Although Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in pre-filled syringe (PFS) presentations in November 2024 and was (together with Steqeyma®) PBS-listed on 1 August 2025.  In August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Omlyclo® in two pre-filled pen (PFP) presentations (75.mg/0.5ml and 150mg/ml).

On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®), in MENA (Middle East and North Africa).

Under the agreements, MS Pharma will be responsible for registration, marketing, and distribution across MENA, while Polpharma will maintain responsibility for development, manufacture and supply.  Both parties have agreed to transfer fill and finish activities to MS Pharma’s biologics manufacturing facility in Saudi Arabia.

In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

There are a number of other vedolizumab biosimilars in development, including by Intas (INTP53) and Alvotech (AVT16).

At least Sandoz (CYB704), Amgen (ABP 692) and Celltrion (CT-P53) have ocrelizumab biosimilars in development, while Alvotech is developing a guselkumab biosimilar which is to be commercialised in the EU, UK and Switzerland by Advanz Pharma.

On 2 September 2025, Shanghai Henlius and Organon announced that the FDA has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.

Shanghai Henlius/Organon’s denosumab biosimilars are the fifth pair to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (launched June 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (launched July 2025), Celltrion’s Stoboclo® and Osenvelt® (launched July 2025) and Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched).

Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 (denosumab) for all countries except China, Hong Kong, Macau and Taiwan.

In June 2025, Amgen sued Henlius and Organon in the US in relation to their denosumab biosimilars, alleging infringement of 26 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.  Amgen also has pending BPCIA litigation against Hikma/Gedeon Richter and Biocon in relation to denosumab.  On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.

On 1 September 2025, STADA announced that international private equity investment firm, CapVest Partners LLP, has signed a definitive agreement to acquire the majority stake in the company.  The transaction is expected to close in H1 2026, subject to regulatory approvals and other closing conditions.

The majority stake in STADA is currently held by Bain Capital and Cinven, which will each retain a minority stake after the CapVest acquisition.

STADA has a number of strategic biosimilars partnerships, including with Bio-Thera in relation to tocilizumab and golimumab biosimilars in the EU, UK and Switzerland, and with Alvotech in relation to Uzpruvo®, the first European approved and launched biosimilar to J&J/Janssen’s Stelara® (ustekinumab) (January/July 2024), biosimilar denosumab (AVT03, MAA accepted by EMA in October 2024) and Hukyndra® (citrate-free 100mg/ml biosimilar adalimumab) launched in Europe in 2022.

In June 2025, STADA’s Afiveg®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), received a positive CHMP opinion for treatment of nAMD and visual impairment due to macular oedema secondary to retinal vein occlusion/diabetic macular oedema (DME)/myopic choroidal neovascularisation.  STADA/Xbrane’s Ximluci®, biosimilar to Genentech’s Lucentis® (ranibizumab), was launched in Europe in April 2023.

On 1 September 2025, Searl announced that it has gained approval from Pakistan’s Drug Regulatory Authority to market and sell its denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®.

In July 2023, Searle entered into a licence agreement with China’s Mabwell Pharmaceuticals, under which Searle will manufacture, register and supply the biosimilars in Pakistan.

Denosumab biosimilars have been approved and launched around the world and, in some countries, are the subject of pending litigation.  For example:

• US: Sandoz (Jubbonti® and Wyost®, launched June 2025), Fresenius Kabi (Conexxence® and Bomyntra®, launched July 2025) and Celltrion (Stoboclo® and Osenvelt®, launched July 2025) all have denosumab biosimilars on the market.  Samsung Bioepis’ Obodence™ and Xbryk™were approved in February 2025.  Amgen has pending US BPCIA litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.  On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.

• Europe: there are 7 sponsors with denosumab biosimilars approved although none have been launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025) and Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025).

• China: Boan Biotech’s Boyoubei® (BA6101), biosimilar to Amgen’s Prolia®, was approved in November 2022, followed by Boluojia® (biosimilar to Xgeva®) in May 2024. Mabwell’s Maiweijian™ (biosimilar to Amgen’s Xgeva®) received marketing approval in April 2024.

• Korea: Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved (November 2024). In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.  Boryung launched Samsung Bioepis’ Xbryk® on 1 August 2025, following its regulatory approval in May 2025.

• Canada: Sandoz launched Jubbonti® and Wyost® in July-August 2024.

• Australia: Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilarsapproved in August 2024, followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).  Jubbonti® and Wyost® were PBS-listed and launched in Australia in August 2025.  Amgen commenced patent infringement against Sandoz in Australia in relation to its denosumab biosimilars in June 2025.

On 1 September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), in relapsed or refractory multiple myeloma.  Celltrion submitted its IND to the EMA in November 2024.

In July 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety approved its IND application for its global Phase 3 clinical trial of CT-P44, which followed approval of its US IND submission in December 2024.

In August 2025, BIOCAD announced that the Russian Ministry of Health had approved its Daratumia®, the first daratumumab biosimilar approved in the country.  This is the first reported regulatory approval for a daratumumab biosimilar worldwide.

Shanghai Henlius also has a daratumumab biosimilar in development, announcing in February 2025 that it entered into a licence agreement with Dr. Reddy’s for HLX15.  In June 2024, Henlius announced the completion of Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.

On 1 September 2025, Australia’s Pharmaceutical Benefits Scheme published its summary of changes for the month of September.  Among the changes was the PBS-listing of Amgen’s supplemental denosumab brands, Corora® (60mg/ml PFS) and Ganvado® (70mg/ml vial), referencing Prolia® and Xgeva®, respectively.

The additional brands are two of the five Amgen brands of denosumab approved by Australia’s TGA in November 2024 (Ganvado™, Zerount™, Corora™, Rexadev™ and Deptargis™).  In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

The PBS-listing of Amgen’s supplemental denosumab brands comes amidst the commencement of biosimilar competition in Australia.  On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed.  Jubbonti® and Wyost® were also the first denosumab biosimilars to be approved in Australia (August 2024), followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).

At its November 2025 meeting, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, for PBS-listing for all reference indications.

In April 2025, Amgen commenced Court proceedings in Australia seeking preliminary discovery of documents from Sandoz in relation to its denosumab biosimilars.  That proceeding concluded and Amgen commenced patent infringement litigation against Sandoz in the Federal Court of Australia in June 2025.

On 1 September 2025, Medical Dialogues reported that Lupin received approval from India’s Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase 1 study of its certolizumab pegol biosimilar in 200mg PFS presentation, referencing UCB’s Cimzia®.

In July 2025, Lupin Limited and Zentiva Group announced that they entered into a global licence and supply agreement for the commercialisation of Lupin’s certolizumab pegol biosimilar.  Under the agreement, Lupin is responsible for development, manufacturing and supply, with split responsibility for commercialisation: Lupin in the US and Canada, with Zentiva in ROW, predominantly Europe and CIS markets.

Alvotech also has a certolizumab pegol biosimilar in development, AVT10, which it acquired from Xbrane in June 2025.  In early July 2025, Alvotech and Advanz Pharma entered a European supply and commercialisation agreement for AVT10.

On 28 August 2025, Celltrion announced that it has launched two biosimilars in Vietnam:

• Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab); and
• Herzuma®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).

Alongside this launch, Celltrion states that it has secured a one-year supply agreement for Remsima® SC with the largest military hospital in Vietnam and a two-year tender to supply Herzuma® to medical institutions in the central and southern regions of the country.

Celltrion has successfully tendered for the supply of Remsima® and Herzuma® in a number of key regions over the past two years, including Brazil (September 2024), and of Remsima SC® in Denmark (April 2024), Norway (February 2024) and Sicily (January 2024).

In February 2024, Celltrion secured a series of tenders in Peru to supply Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yuflyma® (adalimumab biosimilar).  In June 2024, Celltrion successfully applied to be the exclusive supplier of Remsima®, Herzuma® and Vegzelma® (bevacizumab biosimilar) to France’s largest pharmaceutical procurement group (Union des Hopitaux pour les Achats (UniHA)), until 2027.

Earlier this month, Celltrion’s Remsima® IV formulation was recommended for listing on Australia’s Pharmaceutical Benefits Scheme for reimbursement.  Remsima® IV was approved by Australia’s TGA in November 2015, while Remsima® SC received approval in November 2020 (PBS-listed July 2021).

On 28 August 2025, the UK’s NICE published guidance recommending J&J/Janssen’s Tremfya® (guselkumab) for use within England’s NHS for previously treated moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis (UC).

Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease and UC in May 2025 and has been approved for the same indications in the EU (Crohn’s, May 2025; UC, April 2025) and the US (Crohn’s, March 2025; UC, September 2024).

In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 28 August 2025, Outlook Therapeutics announced that the US FDA issued a complete response letter (CRL) declining its BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for treating wet age-related macular degeneration (wet AMD).

Outlook Therapeutics resubmitted its BLA in February 2025 following receipt of a first CRL from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials.

In this latest setback, the FDA recommended Outlook Therapeutics submit additional efficacy data to support its application for ONS-5010.  Outlook intends “to meet with the FDA to receive additional clarity on their requirements to potentially approve the first on-label bevacizumab product specifically formulated, manufactured, and packaged for intravitreal use in the United States”.

In June 2025, the Scottish Medicines Consortium accepted Lytenava™ for use within NHS Scotland for the treatment of wet AMD.  In the same month, Outlook Therapeutics announced that it had launched Lytenava™ in the UK and Germany for wet AMD.

Lytenava™ received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

On 28 August 2025, Bayer announced that it has received approval from Korea’s Ministry of Food and Drug Safety for its OcuClick pre-filled syringe (PFS) presentation of Eylea® 8mg (aflibercept).  The PFS presentation is indicated for nAMD and diabetic macular oedema (DME), the same indications as the vial presentation.

Eylea® 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Eylea® 8mg was approved in Korea in April 2024.  The high dose form of Eylea® is also approved for nAMD, DME and diabetic retinopathy in the US (August 2023) and for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024).  An OcuClick PFS presentation of aflibercept 8mg for nMAD and DME is approved in Canada (February 2025), Australia (October 2024) and Europe (September 2024).

Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg.

On 26 and 27 August 2025, Bio-Thera Solutions and Gedeon Richter announced that the European Commission (EC) has approved BAT2206, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The approval follows the European Medicine Agency’s CHMP positive opinion for the biosimilar on 20 June 2025.

BAT2206 will be commercialised in Europe by Gedeon Richter under the brand name Usymro® subject to a licence and commercialisation agreement entered into with Bio-Thera for Usymro®/BAT2206 in October 2024.  Bio-Thera is responsible for the development and manufacture and Gedeon Richter has commercialisation rights for the EU, UK and Switzerland.  BAT2206 was approved in the US in May 2025 where it will be commercialised by Hikma under the name Starjemza®.

There are a number of ustekinumab biosimilars now marketed in the EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024 and Celltrion’s Steqeyma® launched in November 2024.  Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

On 26 August 2025, Medical Dialogues reported that Aurobindo Pharma subsidiary, CuraTeQ Biologics, has received marketing approval from the UK’s MHRA for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab), for the treatment of HER2-positive breast or gastric cancer.

In July 2025, Dazublys® was approved in the EU for the same indication following the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in April 2025.

Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017).  Other trastuzumab biosimilars since approved in the UK include Amgen’s Kanjinti® (May 2018), Pfizer’s Trazimera® (July 2018), Celltrion’s Herzuma® (January 2021), Biocon’s Ogivri® (January 2021) and Organon’s Ontruzant® (January 2021).

On 26 August 2025, Abbott announced that it has secured regulatory approval for the first denosumab biosimilar, referencing Amgen’s Prolia®/Xgeva®, in Thailand.

Denosumab biosimilars have been approved and launched around the world and, in some countries, are the subject of pending litigation.  For example:

• In the US, Sandoz (Jubbonti® and Wyost®, launched June 2025), Fresenius Kabi (Conexxence® and Bomyntra®, launched July 2025) and Celltrion (Stoboclo® and Osenvelt®, launched July 2025) all have denosumab biosimilars on the market.  Samsung Bioepis’ Obodence™ and Xbryk™ were approved in February 2025.  Amgen has pending US BPCIA litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.  On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.
• In Europe, there are 7 sponsors with denosumab biosimilars approved although none have been launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025) and Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025).
• In China, Boan Biotech’s Boyoubei® (BA6101), biosimilar to Amgen’s Prolia®, was approved in November 2022, followed by Boluojia® (biosimilar to Xgeva®) in May 2024.  Mabwell’s Maiweijian™ (biosimilar to Amgen’s Xgeva®) received marketing approval in April 2024.
• In Korea, Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved (November 2024). In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.  Boryung launched Samsung Bioepis’ Xbryk® on 1 August 2025, following its regulatory approval in May 2025.
• In Canada, Sandoz launched Jubbonti® and Wyost® in July-August 2024.
• In Australia, Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilars approved in August 2024, followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).  Jubbonti® and Wyost® were PBS-listed and launched in Australia in August 2025.  Amgen commenced patent infringement against Sandoz in Australia in relation to its denosumab biosimilars in June 2025.

On 25 August 2025, Bio-Thera and STADA announced that they have extended their strategic biosimilars partnership to cover tocilizumab.  Under the agreement, Bio-Thera will maintain responsibility for development, manufacture and supply of the biosimilar (to Roche’s RoActemra®), while STADA and its affiliates will have exclusive rights to commercialise the biosimilar in the EU, UK, Switzerland and selected other countries.

Bio-Thera and STADA have an existing agreement on similar terms in relation to the exclusive commercialisation of BAT2506 (biosimilar to J&J’s Simponi® (golimumab)), announced in May 2024.  In February 2025, Bio-Thera/STADA’s European marketing authorisation application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA).

Bio-Thera’s tocilizumab biosimilar, BAT1806, was the subject of a commercialisation and licence agreement with Biogen entered in April 2021.  Biogen’s IV tocilizumab, Tofidence®, was approved in the EU in June 2024.

Other tocilizumab biosimilars currently approved in the EU are Fresenius Kabi’s Tyenne®, in both IV and SC forms, approved in November 2023 and Celltrion’s Avtozma®, approved in February 2025.

On 25 August 2025, Ono Pharma and Bristol-Myers Squibb announced that they received supplemental approval in Japan for Opdivo® (nivolumab) and Yervoy® (ipilimumab) in combination therapy for the treatment of unresectable advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer (CRC).  The approval comes nearly a year after the companies submitted the application to Japan’s Ministry of Health, Labour and Welfare.

The Opidvo®/Yervoy® combination has previously been approved for the same indication in Canada (August 2025), Australia (June 2025), the US (April 2025) and EU (December 2024), and was recommended for NHS funding in the UK (April 2025).

In July 2025, the Patent Trial and Appeal Board (PTAB) instituted an inter partes review (IPR), filed by Amgen in February 2025, challenging the validity of a BMS US patent (US11332529) relating to methods of treating colorectal cancer using nivolumab (Opdivo®) and ipilimumab (Yervoy®).

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.

At its July 2025 meeting, Australia’s Pharmaceutical Benefits and Advisory Committee (PBAC) rejected MSD’s proposal for a multi-indication (broad) listing for Keytruda® (pembrolizumab) in advanced or metastatic cancers.  MSD had proposed that Keytruda® be PBS listed for all usages registered on the Australian Register of Therapeutic Goods (ARTG) for such cancers.

However, the PBAC considered that because the proposed funding model “was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration” it “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers.”

MSD said the decision was “bewildering” given “the proposal was developed with the explicit intention of removing immunotherapy access barriers, including for certain rare cancers, where the number of patients involved in a study is often too small to meet requirements for a PBS subsidy”.

In October 2024, PBAC had issued guidance as to the parameters that any broad subsidy proposal for PD-(L)1 inhibitors (such as Keytruda®) would have to address, noting that it was “supportive of implementing simplified listings for PD-(L)1 inhibitors within a specific tumour type if this would facilitate appropriate and timely access for patients”.

At the July 2025 meeting, PBAC also recommended against PBS listing of Keytruda® for the treatment of primary advanced or recurrent endometrial cancer.

On 22 August2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) July 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).

Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu™, have been recommended for PBS-listing under the same circumstances as reference biologic, Regeneron/Bayer’s Eylea®.  Sandoz’s Afqlir® and Enzeevu® were approved by the TGA on 27 May 2025 and were the first aflibercept biosimilars to be considered (and now recommended) for reimbursement.  Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).

Biocon Biologic’s Nepexto® (pre-filled syringe), biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was also recommended for PBS-listing (sponsor: Maxx Pharma).  Nepexto® (50mg/1ml auto-injector) became the second etanercept biosimilar to be PBS-listed as of 1 July 2025, following Samsung Bioepis/Arrow Pharma’s Brenzys® in April 2017.  In July 2025, Biocon Biologics announced that it launched Nepexto® in Australia.

Celltrion’s Remsima® (IV formulation), biosimilar to Janssen’s Remicade® (infliximab), has also been recommended by PBAC.  Remsima® IV was approved by the TGA in November 2015, while Remsima® SC received approval in November 2020 (PBS-listed July 2021).

Among the originator biopharmaceuticals, Roche/Genentech’s Ocrevus® (ocrelizumab) SC formulation was recommended for PBS listing under the same circumstances as the IV formulation, following its approval in Australia in March 2025.

There are a number of ocrelizumab biosimilars currently in development.  On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its nivolumab and ocrelizumab biosimilars, which includes modifying its Phase 1/3 trial for biosimilar ocrelizumab, CYB704, so that it will become a comparative pharmacokinetic trial.  In January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) undergoing Phase 3 trials.  Celltrion also has an ocrelizumab biosimilar in development, announcing in August 2023 that the European Medicines Agency (EMA) had partially approved its Phase 3 IND for CT-P53 (ocrelizumab).

On 22 August 2025, BIOCAD announced that the Russian Ministry of Health has approved Daratumia®, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), as the first daratumumab biosimilar approved in the country.  This is the first reported regulatory approval for a daratumumab biosimilar that has been identified to date worldwide.

There are a number of daratumumab biosimilars currently in development.  In July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44, to evaluate and compare the efficacy and safety of Darzalex® and CT-P44 over a two-year period in 486 patients with relapsed or refractory multiple myeloma.

Shanghai Henlius also has a daratumumab biosimilar in development, announcing in February 2025 that it entered into a licence agreement with Dr. Reddy’s for HLX15.  In June 2024, Henlius completed Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.

On 21 August 2025, New Zealand’s Medsafe approved Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), in 100mg IV formulation for all reference indications.

Ixifi® will be the second infliximab biosimilar available in New Zealand, following Celltrion’s Remsima® (SC formulation, 120mg/ml pre-filled pen and pre-filled syringe), approved in June 2023.

Pfizer’s Inflectra® branded infliximab biosimilar (100mg IV formulation) was initially approved by Medsafe in September 2015, but the company no longer supplies or markets the product.  Similarly, Samsung Bioepis’ infliximab biosimilar, Renflexis® (100mg IV formulation), was approved by Medsafe in March 2023, but is also no longer supplied or marketed in New Zealand.

Pfizer and Celltrion entered into a 2009 agreement for biosimilar infliximab, with Pfizer holding exclusive commercialisation rights in the US and certain other jurisdictions.  In March 2025, Celltrion announced the rebrand of Inflectra® (IV formulation) to Remdantry™ in Canada.  According to Celltrion, the rebrand reflected its “consolidation of both the intravenous (IV) and subcutaneous (SC) formulations” being directly commercialised by Celltrion in Canada in order to “provide healthcare professionals with a more streamlined prescribing experience”.

On 21 August 2025, BioDlink (previously known as TOT BIOPHARM) announced that its Bevacizumab Injection, biosimilar to Roche/Genentech’s Avastin®, has received marketing approval from Indonesia’s National Agency of Drug and Food Control (BPOM).

This news comes just days after BioDlink’s 13 August 2025 announcement that its biosimilar bevacizumab received marketing approval from Pakistan’s Drug Regulatory Authority of Pakistan (DRAP) and Colombia’s National Institute for Surveillance of Medicines and Foods (INVIMA).

BioDlink’s manufacturing facility has received GMP certification in China, Colombia, Brazil, Argentina, Egypt, Indonesia and Pakistan and its global licensee for the bevacizumab biosimilar in emerging markets, Kexing Biopharm, has initiated regulatory filings in 35 countries.

On 21 August 2025, Alvotech and Advanz Pharma announced that Mynzepli® (AVT06), biosimilar to Regeneron/Bayer’s 2mg Eylea® (aflibercept) has been approved by the European Commission in pre-filled syringe and vial presentations.  Mynzepli® received a positive CHMP opinion in June 2025 and is approved across all Eylea® indications.

Alvotech and Advanz Pharma entered into an agreement in relation to the European commercialisation of AVT06 in June 2024.  Under the agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive.  The agreement also covers Alvotech’s AVT29, biosimilar to high-dose (8mg) Eylea®.

In February 2025, Alvotech’s AVT06 BLA was accepted in the US, where it will be commercialised by Teva.  Alvotech and Teva are expecting FDA approval in Q4 2025.

There are 8 other aflibercept (2mg) biosimilars approved in Europe, none of which have launched to date: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025).  Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.

On 20 August 2025, Regeneron announced that the FDA has extended its target action dates to Q4/2025 for two Eylea HD® (aflibercept, 8mg) regulatory submissions:

• a supplemental BLA (accepted by the FDA for Priority Review in April 2025) seeking approval for the treatment of macular oedema following retinal vein occlusion (RVO) and an extension of the dosing schedule to include every 4-week dosing across approved indications; and
• a prior approval supplement for the Eylea HD® pre-filled syringe.

The extension to the review period is a result of FDA observations based on a site inspection at the filling site owned by Novo Nordisk (previously Catalent).  Novo Nordisk submitted a response in early August 2025 to address the FDA’s observations.

Eylea HD® (known as Eylea™ 8mg in Europe) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Eylea HD® is approved for nAMD, DME and diabetic retinopathy in the US (August 2023).  Eylea™ 8mg for intravitreal injection is approved for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024).  Eylea™ 8mg pre-filled syringe (OcuClick) was approved in Australia (October 2024) and Europe (September 2024).  In addition to the US application, Regeneron/Bayer have submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea™ 8mg.

On 20 August 2025, Korea Biomedical Review reported that Sam Chun Dang’s biosimilar of Regeneron/Bayer’s 2mg Eylea® (aflibercept) received European marketing authorisation in both vial and pre-filled syringe forms (PFS).

According to the report, Sam Chun Dang (SCD) considers it may be the first to launch a PFS aflibercept biosimilar in Europe, after being the first to do so in Canada.  SCD intends to launch the product in Europe “once Eylea®’s patents expire” but has not revealed its EU pricing or distribution partners due to contractual restrictions.

In March 2024, SCD entered an agreement with an unnamed distributor to supply SCD-411 (biosimilar aflibercept) in the UK, Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland, and Finland.  SCD-411 was also the subject of an exclusive distribution agreement reported in November 2023, between SCD and an unnamed distributor, for supply to Austria, Germany, Italy, Spain, and Switzerland.

SCD announced on 2 July 2025 that SCD-411 received product approval from the Canadian Ministry of Health on 26 June 2025, with sales commencing in July 2025.  This announcement was made the same day that Apotex announced that its Aflivu™ (aflibercept) had been approved by Health Canada in pre-filled syringe and vial formats.  While it was reported in August 2023 that SCD had licensed its aflibercept biosimilar to Apotex for Canada, neither Apotex nor SCD have since referred to this relationship.

On 20 December 2024, Fresenius Kabi announced that it had entered into a licensing agreement with SCD to exclusively commercialise SCD-411 in the United States, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico.

SCD is currently engaged in litigation with Regeneron/Bayer in South Korea relating to Regeneron’s Korean Patent No. 659477.  Regeneron/Bayer filed the lawsuit in January 2024 alleging that SCD’s licence agreement with an unnamed overseas company to supply SCD-411 constituted an infringement of the patent.

Other aflibercept (2mg) biosimilars presently approved in Europe, none of which have yet launched, are: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), and Amgen’s Pavblu® (April 2025).

On 19 August 2025, BMS announced that Health Canada has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer (CRC), and for unresectable or advanced hepatocellular carcinoma (HCC).

This follows recent approvals of the combination therapy for HCC in Taiwan (July 2025), Korea (July 2025), Japan (June 2025), the US (April 2025) and EU (March 2025); and for CRC in the US (April 2025) and Australia (June 2025).

In July 2025, the Patent Trial and Appeal Board (PTAB) instituted an inter partes review (IPR), filed by Amgen in February 2025, challenging the validity of a BMS US patent (US11332529) relating to methods of treating colorectal cancer using nivolumab (Opdivo®) and ipilimumab (Yervoy®).

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development.  Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.  In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for an ipilimumab biosimilar.

On 19 August 2025, CSPC Pharmaceutical announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection, biosimilar to Sanofi/Regeneron’s Dupixent®.  According to CSPC, the product, which is indicated for the treatment of moderate-to-severe atopic dermatitis in adults, has been demonstrated to be highly similar to Dupixent® in terms of quality, safety and efficacy in pharmaceutical and non-clinical studies.

There are a number of other dupilumab biosimilars under development.  In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.

Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries, with Alvotech responsible for development, and Advanz responsible for commercialisation.

On 18 August 2025, MedImpact Holdings Inc. announced that, from 1 January 2026, Teva subsidiary Anda’s unbranded ustekinumab-aekn (biosimilar to J&J/Janssen’s Stelara®) will be available for direct purchase from MedImpact’s preferred partner, Birdi, Inc., by any licensed specialty pharmacy.

Separately, CivicaScript announced earlier this month that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz in the US from 1 January 2026.

MedImpact’s announcement follows Alvotech’s and Teva’s announcement in May 2025 that the FDA had approved Selarsdi® as interchangeable with Stelara® in all presentations, including for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

Selarsdi® was the second ustekinumab biosimilar launched in the US, in February 2025, following a settlement between Alvotech/Teva and J&J entered in June 2023, which permitted the US launch of the biosimilar from 21 February 2025.  Other ustekinumab biosimilars that have been launched in the US to date are: Amgen’s Wezlana® (January 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025), Biocon’s Yesintek® (February 2025), Formycon/Fresenius Kabi’s Otulfi® (March 2025) and Celltrion’s Steqeyma® (March 2025).

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates.  The partnership was expanded in July 2023 to include four additional products.

On 18 August 2025, Accord BioPharma announced the US commercial launch of Imuldosa® PFS, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The Imuldosa® syringes are to be supplied at the lowest wholesaler acquisition cost (WAC) price among branded ustekinumab biosimilars.

Imuldosa® (DMB-3115) was FDA-approved in October 2024.  It was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas Pharmaceuticals (Accord BioPharma’s parent company) exclusive licensing rights worldwide, excluding certain Asian countries, in an agreement announced in 2021.  Under the agreement, Accord BioPharma is responsible for US commercialisation.

There are a number of ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (January 2025), Alvotech/Teva’s Selarsdi® (February 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025), Biocon’s Yesintek® (February 2025), Formycon/Fresenius Kabi’s Otulfi® (March 2025) and Celltrion’s Steqeyma® (March 2025).

On 14 August 2025, Genentech and Hoffman-La Roche filed BPCIA litigation in the US District Court for the District of New Jersey alleging infringement of 24 US patents relating to their Perjeta® branded pertuzumab cancer treatment.  The allegations relate to Shanghai Henlius’ (in conjunction with Organon) application to the FDA for approval of its pertuzumab biosimilar, HLX11, which was accepted in January 2025.

The asserted patents cover pertuzumab, pharmaceutical compositions comprising pertuzumab, methods of treatment using pertuzumab, and methods of manufacturing therapeutic antibodies like pertuzumab and are US7862817, US865474, US9181346, US11414498, US11597776, US12110341, US7449184, US8404234, US10689457, US11655305, US11077189, US11638756, US11992529, US12128103, US10808037, US11078294, US12145997, US12173080, US9815904, US9969811, US12415998, US10662237, US10676710, and US12103975.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

This action comes less than a month after Roche acknowledged that biosimilar competition to Perjeta® was closer than it previously anticipated, and just over a quarter since Roche downplayed the potential threat from Henlius.  HLX11 is under also consideration for approval in Europe (March 2025) and China (December 2024).

Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.

Paraguay-headquartered Bioéticos, which is part of Laboratorio Productos Eticos C.E.I.S.A (a member of Savone Holding and part of Insud Pharma) claims to have launched the first pembrolizumab biosimilar in Paraguay, under the name Pembrolizumab Bioéticos.  According to a banner currently appearing on Bioéticos’ website, and a May 2025 LinkedIn post, the biosimilar to MSD’s Keytruda® was developed by mAbxience.

However, in an article dated 14 August 2025, Generics and Biosimilars Initiative noted that as of mid-May 2025, there was no indication that Paraguay’s regulatory authority, DINAVISA (Dirección Nacional de Vigilancia Sanitaria), had officially approved a pembrolizumab biosimilar for use in Paraguay.

There have been no announcements by mAbxience in relation to the product.  Based on the clinicaltrials.gov database, mAbxience is undertaking a Ph 3 study to compare the PK, efficacy, safety and immunogenicity of MB12 (biosimilar pembrolizumab) versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic nsNSCLC.  The study commenced in December 2024 and is currently recruiting, with estimated primary completion in June 2026.

On 13 August 2025, Shanghai Henlius and Hong Kong-headquartered EssexBio announced that China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted for review their New Drug Application (NDA) for HLX04-0, an ophthalmic preparation product based on Henlius’ biosimilar to Roche/Genentech’s Avastin® (bevacizumab).  HLX04-O is intended for the treatment of wet AMD.

The companies entered into a co-development and exclusive licensing agreement in October 2020, under which EssexBio was granted an exclusive licence to develop, manufacture and commercialise HLX04 (biosimilar bevacizumab) globally.

The first and only authorised ophthalmic formulation of bevacizumab in the EU and UK, Lytenava™ (bevacizumab gamma, ONS-5010), which received EU approval in May 2024 and UK approval in July 2024, was launched in the UK and Germany in June 2025 by Outlook Therapeutics.  In the US, the product is still under regulatory consideration, with Outlook Therapeutics having resubmitted its BLA to the FDA in February 2025, after receiving a complete response letter in 2023.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD in March 2025.

On 12 August 2025, Celltrion announced that it has been awarded a series of supply contracts in Italy for its autoimmune disease therapies and oncology treatments.  Key contracts include additional contracts for Steqeyma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in the Veneto, Trentino-Alto Adige, and Sardinia regions, following contracts for four regions earlier this year.  This means that Celltrion will now supply Steqeyma® to seven regions in total through to May 2026.

Steqeyma® was approved in Europe in August 2024, following a positive CHMP opinion in June 2024.  Celltrion launched Steqeyma® in Italy in mid-January 2025, with Celltrion confirming on 23 January 2025 that it had completed the launch of Steqeyma® in Italy, France, Spain, the UK, and Germany.  Celltrion was the third company to launch an ustekinumab biosimilar in Europe.

On 22 July 2024, STADA and Alvotech announced the launch of biosimilar ustekinumab Uzpruvo® across the majority of European countries.  This was quickly followed by Sandoz announcing the European launch of Pyzchiva® on 25 July 2024.

On 12 August 2025, Lupin announced that it has partnered with Sandoz to market and commercialise Lupin’s biosimilar ranibizumab (referencing Genentech’s Lucentis®) across the European Union (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam, and Malaysia.  

Sandoz has exclusive marketing rights in most of the designated markets, except for France, Australia, Vietnam, and Malaysia, where it has semi-exclusive marketing rights.  Lupin remains responsible for manufacturing the product and for regulatory submissions.

Lupin is one a of a number of companies with ranibizumab biosimilars.  Other ranibizumab biosimilars include Samsung Bioepis’ Byooviz® (EU-approved in September 2021, FDA-approved in September 2021); Formycon’s Ranivisio® (EU-approved in August 2022); Sandoz’s Cimerli® (FDA-approved in August 2022) and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).

On 12 August 2025, the Swiss Federal Patent Court upheld Samsung Bioepis’ invalidity action against the Swiss and Liechtenstein part of Janssen Biotech’s European Patent 3883606.  Janssen’s ‘606 patent relates to the use of ustekinumab (the active ingredient in Stelara®) in the treatment of ulcerative colitis.

The Swiss action is part of a global suite of actions between Samsung Bioepis and Janssen, with Samsung Bioepis having recently claimed victory in other key jurisdictions including:

• UK: In a decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of ustekinumab for treating ulcerative colitis, was invalid.
• Canada: On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings.  Samsung Bioepis commenced proceedings against Janssen seeking to invalidate Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023.
• EU: In April 2025, Samsung Bioepis successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.
• US: Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar.  J&J filed an appeal on 30 April 2025.
• Australia: On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  The Court’s revocation orders, made before the scheduled end of the trial, concluded patent infringement proceedings commenced by Janssen Biotech (and Janssen-Cilag Pty Ltd) against Samsung Bioepis in August 2024.  The Janssen innovation patents all related to a method of treating ulcerative colitis with ustekinumab.

On 11 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved a new brand of Novartis’ ofatumumab:

• ZOPHEOS ofatumumab 20 mg/0.4mL solution for injection pre-filled pen (490662)
• ZOPHEOS ofatumumab 20 mg/0.4mL solution for injection pre-filled syringe (490650)

These presentations mirror Novartis’ previously approved ofatumumab product under the original Kesimpta® brand (approved March 2021), as well as second brand Bonspri™ (approved January 2022).  Kesimpta® was listed on Australia’s Pharmaceutical Benefits Scheme in October 2021.

Biosimilar competition for ofatumumab appears to be on the way, with Alvotech and Advanz Pharma announcing in May 2025 that they entered a supply and commercialisation agreement to expand their existing partnership to cover three additional biosimilar candidates in Europe, including biosimilars to Kesimpta®, as well as Novartis’ Ilaris® (canakinumab) and a third, undisclosed early-stage biosimilar.

On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its nivolumab and ocrelizumab biosimilars, following “ongoing encouraging and favourable regulatory developments” and feedback from major regulatory authorities regarding the requirements for biosimilar approvals.

Sandoz has suspended its Phase 3 trial for JPB898, biosimilar to BMS’ Opdivo® (nivolumab), administered in combination with Yervoy® (ipilimumab) in patients with unresectable Stage III or metastatic Stage IV melanoma.  It is modifying its Phase 1/3 trial for CYB704, biosimilar to Genentech’s Ocrevus® (ocrelizumab), so that it will become a comparative pharmacokinetic trial.

Sandoz’s decision to streamline its nivolumab and ocrelizumab clinical trials follows its April 2025 announcement that it is “minimising” its Phase 3 trial of GME751, biosimilar to MSD’s Keytruda® (pembrolizumab), in patients with untreated metastatic non-squamous NSCLC.  Sandoz is continuing its Phase 1 trial of the pembrolizumab biosimilar in patients with resected advanced melanoma.

In February 2025, Formycon similarly announced the premature termination of its “Lotus” Phase 3 trial of FYB206, biosimilar to Keytruda®.  According to Formycon, following “intensive scientific dialogue” with the US FDA, it concluded that the Phase 3 study was no longer necessary for the development and US approval of FYB206.  Instead, Formycon will be relying on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.

On 6 August 2025, Celltrion announced that the US FDA has approved an expanded indication for its IV formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of cytokine release syndrome (CRS) in adults and paediatric patients aged 2 years and older.  With this approval, Avtozma® IV now aligns with all reference indications of Actemra® IV in the US.

Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025), trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and will be considered for PBS-listing at PBAC’s November 2025 meeting.

On 6 August 2025, Intas Pharmaceuticals, and its global subsidiaries operating under the Accord brand, announced the successful acquisition of Udenyca®, biosimilar to Amgen’s Neulasta® (pegfilgrastim), from Coherus Biosciences.  The addition of Udenyca® expands Intas and Accord’s biosimilar portfolio, which already includes Accord’s other biosimilar pegfilgrastim, Pelgraz®.

The successful acquisition of Udenyca® follows announcement of the agreement for its sale in December 2024 under which Coherus would receive USD$483.4 million upfront, with up to USD$75 million in potential milestone payments based on net sales performance.

In March 2025, Coherus further announced that it will transfer approximately 50 employees to Intas Pharmaceuticals’ specialty unit, Accord BioPharma.  The move will reduce Coherus’ workforce by around 30%, leaving it with approximately 155 employees.

On 5 August 2025, Actor Pharmaceuticals filed legal proceedings against Regeneron and Bayer in the Australian Federal Court.  While the details of the proceedings have not yet been published, it is expected that the proceedings are likely to relate to one or more Australian patents regarding Regeneron/Bayer’s Eylea® (aflibercept).  The first case management hearing in the proceeding is listed for 8 September 2025.

If the litigation commenced by Actor does relate to aflibercept, it will not be the first Australian aflibercept litigation.  On 4 June 2025, Regeneron and Bayer filed proceedings in the Federal Court against Sandoz alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders.  Regeneron is seeking both an interlocutory injunction and final relief, with the hearing of the interlocutory injunction scheduled for 14 August 2025.  Regeneron/Bayer have also filed an application for preliminary discovery in relation to a second of Regeneron’s Australian aflibercept patents, scheduled for hearing on 27 August 2025.

Actor does not currently have any aflibercept biosimilars registered in its name on the ARTG.  Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).  Sandoz’s Afqlir® and Enzeevu® were approved by the TGA on 27 May 2025 and were the first to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting.

On 5 August 2025, Polpharma Biologics and Fresenius Kabi announced that they have entered into a global licensing agreement (excluding Middle East & North Africa) for the commercialisation of PB016, biosimilar to Takeda’s Entyvio® (vedolizumab).  PB016 was developed by Polpharma, which will remain responsible for manufacture.  Fresenius Kabi will be responsible for commercialisation.

In February 2024, Polpharma Biologics announced that PB016 demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.  Phase 3 trials comparing PB016 to Entyvio® are underway, with estimated completion in September 2025.

There are a number of other vedolizumab biosimilars in development.  In February 2025, Intas Pharmaceuticals received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)).  In September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis.  Alvotech’s AVT16 is subject to a 2023 licence agreement with Advanz, under which Advanz will commercialise the biosimilar in Europe, the UK and Switzerland.

On 5 August 2025,  CivicaScript, LLC announced that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz, biosimilar to J&J/Janssen’s Stelara®, in the US from 1 January 2026.  CivicaScript is a nonprofit company dedicated to bringing low-cost generic medicines to US patients, and will be the exclusive distributor of Fresenius Kabi’s unbranded ustekinumab-aauz.

Fresenius Kabi has already launched its branded ustekinumab biosimilar, Otulfi®, in the US in March 2025 and in Canada in May 2025.  Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024 and in Canada and the UK in January 2025.  It is being commercialised in Canada, the US, and most of Europe by Fresenius Kabi under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In August 2023, Formycon and Fresenius reached a settlement with J&J in the US, enabling US launch of FYB202 “no later than 15 April 2025” (the biosimilar’s US launch was in early March 2025).  This was followed by a settlement in March 2024 regarding the commercialisation of FYB202/Otulfi® in Europe and Canada, with the launch dates in those countries previously undisclosed.

On 5 August 2025, Kashiv BioSciences and MS Pharma announced that they entered into a licence and supply agreement for Kashiv’s ADL-018, biosimilar to Novartis’ Xolair® (omalizumab), for the Middle East and North Africa (MENA).

Under the terms of the agreement, Kashiv is responsible for the development of the biosimilar and MS Pharma is responsible for licensing, distribution, and commercialisation in the MENA region.  The agreement also provides an option for MS Pharma to manufacture the biosimilar in Saudi Arabia.  MS Pharma is expected to submit an application for regulatory approval of ADL-018 in MENA countries in Q4 2025.

In October 2023, Kashiv entered into an exclusive licensing agreement with Alvotech in relation to the commercialisation of Kashiv’s omalizumab biosimilar in the EU, UK, Australia, Canada and New Zealand.  Alvotech and Advanz Pharma subsequently entered into an agreement in relation to the commercialisation of omalizumab (AVT23) in those countries.  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

On 4 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in two pre-filled pen (PFP) presentations (75.mg/0.5ml and 150mg/ml).

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia, and was first approved in pre-filled syringe (PFS) presentations in November 2024, which were listed on the Pharmaceutical Benefits Scheme (PBS) on 1 August 2025.

Omlyclo® is also approved in the EU (May 2024), Korea (June 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  It has been the subject of legal disputes in at least the UK and Europe.

Kashiv Biosciences/Alvotech had a marketing application for omalizumab biosimilar AVT32 accepted in the UK in March 2025, while other companies, including Aurobindo, Teva and Glenmark, reportedly have omalizumab biosimilars under development.

On 14 July 2025, Fresenius Kabi filed petitions for IPR (inter partes review) against Regeneron’s US Patent No. 11,084,865 to ophthalmic formulations of aflibercept and US Patent No. 10,828,345 to methods of treating angiogenic eye disorders.  Fresenius is seeking to overturn claims 1-5, 7-30, and 32-50 of the 865 patent based on anticipation, and all claims of the 345 patent based on anticipation and obviousness.

Samsung Bioepis, Formycon and Celltrion had previously also challenged the validity of Regeneron’s US 11,084,865 before the USPTO, filing petitions for IPR in November 2024, December 2024 and January 2025, respectively.  On 2 June 2025, the PTAB denied institution of Samsung Bioepis’ and Formycon’s petitions, including because the 865 patent is already the subject of pending BPCIA litigation involving the parties.  Celltrion’s petition was denied on 26 June 2025 for similar reasons.  Notably, Fresenius is not currently a party to any BPCIA aflibercept litigation brought by Regeneron.

Regeneron is in BPCIA litigation against each of Amgen (Pavblu™), Samsung Bioepis (2 actions; Opuviz™/SB15), Formycon (Ahzantive®/FYB203), Celltrion (2 actions, CT-P42) and Sandoz (Enzeevu™) regarding biosimilar aflibercept.  Preliminary injunctions were granted, and remain in place, preventing biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).

Fresenius entered into a licensing agreement with Sam Chun Dang in December 2024 for the exclusive commercialisation of SCD-411, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg), in the US and various South American countries.  The only biosimilar aflibercept currently available in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).  Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Biocon’s biosimilar, Yesafili™, in the second half of 2026, or earlier under certain undisclosed circumstances.

On 4 August 2025, Celltrion announced that, according to market research firm IQVIA, Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), reached 24% market share in Europe in Q1 2025, up 3% on the previous quarter and now only one percentage point behind the leading product.

Celltrion stated that this is a “significant achievement” given that Yuflyma® joined the top prescription tier three years later than its competitors and in a “highly competitive market with over 10 adalimumab products”, including originator product Humira®.

In April 2025, Celltrion announced that it secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free presentation of Yuflyma®.  There are a number of high concentration adalimumab biosimilars approved in the US, including: Samsung Bioepis’ Hadlima™, Amgen’s Amjevita®, Sandoz’s Hyrimoz®, and Boehringer Ingelheim’s Cyltezo®.

As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas Pharmaceuticals Ltd. for its proposed denosumab biosimilar.  In the CSR, data was presented from a randomised Phase I trial for Intas’ 120 mg / 1.7 mg denosumab injection.

On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following:

• Sandoz’s Wyost® and Jubbonti®, the first biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) to be PBS listed;
• Celltrion’s Steqeyma®, the first biosimilar to Janssen’s Stelara® (ustekinumab) to be PBS listed; and
• Celltrion’s Omlyclo®, the first biosimilar to Genentech/Novartis’ Xolair® (omalizumab) to be PBS listed.

Each of these biosimilars is PBS listed for all reference indications.

On the same day, Arrotex Pharmaceuticals announced that it has entered into a strategic licensing agreement with Celltrion to commercialise the Celltrion ustekinumab and omalizumab biosimilars in Australia.

Celltrion’s Omlyclo® is the only omalizumab biosimilar approved in Australia (November 2024), and was recommended for reimbursement at PBAC’s March 2025 meeting.  Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

Sandoz’s Wyost® and Jubbonti® and Celltrion’s Steqeyma® were recommended for listing in Australia at the November 2024 PBAC meeting.

Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing at the March 2024 PBAC meeting, but Amgen is not proceeding with the PBS-listing and the PBAC process has ceased.  Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was recommended for PBS-listing at PBAC’s March 2025 meeting.  However, the current status of the PBS application indicates that it is inactive as Samsung Bioepis has not advised whether it intends to proceed or not within 60 days of receiving the ratified PBAC minutes.

At the November 2025 meeting, PBAC will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt® for PBS-listing for all reference indications.

On 1 August 2025, the Korea Biomedical Review reported that Boryung launched Samsung Bioepis’ denosumab biosimilar (Xbryk™) in the Korean market, following its regulatory approval in May 2025.  Xbryk™ is a biosimilar to Amgen’s Xgeva® and is approved to prevent skeletal complications in patients with bone metastases and to treat giant cell tumour of bone.

Samsung Bioepis and Boryung announced on 2 July 2025 that they entered into an exclusive licensing deal in relation to Xbryk™, one day after Samsung Bioepis and Hanmi Pharmaceuticals announced their joint South Korean launch of Samsung Bioepis’ Obodence™, biosimilar to Amgen’s Prolia® (denosumab).

Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved in Korea (November 2024).  In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.

On 30 July 2025, Sandoz and Evotec announced that they have signed a non-binding term sheet relating to Sandoz’s potential acquisition of Just-Evotec Biologics EU and its J.POD® biologics manufacturing facility in Toulouse, France.  Under the proposed arrangement, Sandoz would also be granted access to Evotec’s proprietary platform for integrated development and advanced continuous manufacturing of biologics via a technology licence.

The proposed transaction would result in Sandoz acquiring 100% of the issued and outstanding equity interest of Just-Evotec for approximately USD 300 million.  According to Evotec, the deal will further encompass additional technology related consideration, future development revenues, milestones and product royalties.

Sandoz intends to use the Toulouse site to develop and manufacture Sandoz biosimilars, reinforcing its in-house biosimilar capabilities, while creating additional strategic flexibility.  Upon completion of the proposed transaction, Just-Evotec’s employees would transfer with the acquired entity and would become part of the Sandoz Group.  Finalisation of the proposed transaction is subject to negotiation of contractual details and obtaining necessary approvals.

Sandoz and Just-Evotec have partnered in relation to the development and manufacturing of biosimilars since May 2023.  That partnership was expanded in July 2024.

On 1 July 2025, Sandoz announced that it had commenced construction of a new biosimilar production centre in Slovenia, due to open in 2028, to expand Sandoz’s European biosimilar manufacturing capacity.

On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered:

• Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg), for all reference indications;
• Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), for all reference indications; and
• Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for all reference indications.

Biosimilar aflibercept

Celltrion’s Eydenzelt® (approved March 2025) is the second aflibercept biosimilar to be considered by PBAC, following Sandoz’s aflibercept biosimilars Afqlir® and Enzeevu™, which were approved in May 2025 and considered by PBAC in July 2025.  The outcomes of the July 2025 meeting have not yet been published.  Beyond those of Sandoz and Celltrion, there are no other aflibercept biosimilars approved in Australia.

Biosimilar denosumab

In December 2024, Sandoz’s denosumab biosimilars, Jubbonti® and Wyost®, were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).  Jubbonti® and Wyost® were the first denosumab biosimilars approved in August 2024, followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).  In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia.  In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

Biosimilar tocilizumab

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and to be considered for PBS-listing.  In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence™ in June 2024.

Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025), trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 29 July 2025, in a report to its shareholders, Celltrion announced that it has been designated as the preferred bidder for an undisclosed large-scale cGMP US manufacturing plant owned by a global pharmaceutical company.  Celltrion is expecting to complete the acquisition in early October 2025.

According to Celltrion, the US manufacturing plant acquisition is part of its “US tariff response strategy”.  Celltrion’s strategy to minimise the impact of “US pharmaceutical tariff policies” also includes stockpiling of two years’ worth of inventory within the US and expanding contracts with local CMO companies to enable US domestic production of products sold in the US.

Celltrion expects the acquisition of the US manufacturing facility to have additional benefits, including strengthening its market responsiveness and generating immediate revenue due to an agreement that will permit Celltrion to use half the plant’s capacity to exclusively produce the current plant owner’s biologics for the next 5 years.

On 25 July 2025, the High Court of Delhi issued an interlocutory judgment in ongoing patent infringement litigation brought by Roche to prevent Zydus from launching Sigrima®, biosimilar to Roche’s Perjeta® (pertuzumab), in India.

One of Roche’s patents in suit, IN464646, claims a process for making a composition comprising pertuzumab.  Roche had sought disclosure, on a confidential basis, of Zydus’ manufacturing process for Sigrima®.  Roche invoked section 104A of India’s Patents Act 1970, under which a defendant may carry the burden of proving non-infringement of a patent that claims a process for producing a product, if the defendant’s product is shown to be “identical” to one produced by the patented process.

The Court found that Roche had not proved that Sigrima® was “identical” to the product of the patented process.  Roche’s only evidence was the use by Zydus of Perjeta® as the reference drug for Sigrima®.  This was only sufficient to prove that Sigrima® met the regulatory guidelines for biosimilarity but not that it was “identical” to Perjeta®.  It remains open to Roche to prove the products are identical by other means in the substantive trial.

Zydus is also facing infringement proceedings in India alleging that Zydus’s ZRCr-4276, biosimilar nivolumab, infringes BMS’ patent IN340060, which protects Opdivo® (nivolumab, branded as Opdyta® in India).

On 25 July 2025, Ono Pharmaceutical Co announced the additional approval by the Taiwan Food and Drug Administration (TFDA) of Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as intravenous infusion for first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.

This follows closely behind approvals of the same indication in Korea (July 2025), Japan (June 2025), the US (April 2025), and the EU (March 2025).

In 2011, Ono granted BMS commercialisation rights for Opdivo®, excluding in Japan, South Korea and Taiwan, where Ono retains all rights.  In July 2014, Ono and BMS agreed to expand their collaboration agreement to jointly develop and commercialise multiple immunotherapies as single agent and combination regimens for cancer in Japan, South Korea and Taiwan.

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development.  In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).

On 25 July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its July meeting, with positive opinions for the following denosumab, aflibercept and ustekinumab biosimilars:

• Shanghai Henlius’ Bildyos® and Bilprevda®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), were recommended for all indications of the reference products. Henlius’ marketing authorisation application for the biosimilars (HLX14) had been accepted by the EMA in May 2024.  In June 2022, Henlius entered into a licence agreement with Organon regarding HLX14 under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.  Henlius and Organon were sued by Amgen in the US in relation to their denosumab biosimilars in June 2025.
• Alteogen’s Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), received a positive CHMP opinion for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation. Alteogen submitted its MAA in July 2024.
• Biocon’s Usrenty®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), was recommended for treatment of moderate to severe plaque psoriasis in adults and children from the age of 6, active psoriatic arthritis in adults and moderately to severely active Crohn’s disease in adults. Biocon received European Commission approval for another ustekinumab biosimilar Yesintek® (Bmab 1200) in February 2025 for the same indications.  In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen which enables commercialisation of its ustekinumab biosimilar in Europe, the United Kingdom, Canada and Japan (launch date unknown).

There are currently 6 sponsors with denosumab biosimilars approved in Europe, although none have yet been launched:  Sandoz’s Wyost® and Jubbonti® (May 2024), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce® and Biocon’s Evfraxy® and Vevzuo® (each in early July 2025), and Fresenius’ Conexxence® and Bomyntra® (late July 2025).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted denosumab biosimilar MAAs including for Teva (TVB-009P, October 2024) and STADA/Alvotech (AVT03, October 2024).

There are 7 aflibercept (2mg) biosimilars approved in Europe and not yet launched: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), and Amgen’s Pavblu® (April 2025).

There are a number of ustekinumab biosimilars now marketed in the EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024 and Celltrion’s Steqeyma® launched in November 2024.  Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

Roche’s 2025 second-quarter earnings call included disclosure that it now expects biosimilar competition to Perjeta® (pertuzumab) and Xolair® (omalizumab) in 2026, sooner than previously anticipated.

In its previous quarterly earnings call in April 2025, Roche had said that it did not expect competition to Perjeta® until late 2027.  The biosimilar expected to provide the first serious competition remains Henlius/Organon’s HLX11, which is being considered for approval in Europe, the US, and China.  Organon’s own earnings call is scheduled for 5 August 2025.  Other pertuzumab biosimilars have been approved in India (Zydus and Intas) and Russia (Biocad).

Celltrion’s Omlyclo® (omalizumab) is already approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  It has been the subject of legal disputes in at least the UK and Europe.

On 24 July 2025, Reuters reported that Dr Reddy’s CEO, Erez Israeli, stated the company plans to launch its generic version of Novo Nordisk’s Wegovy® (semaglutide), in 87 countries in 2026, beginning with Canada, India, Brazil, Turkey and other emerging markets, subject to patent expiry.

Israeli stated that the “U.S. and Europe will open later… (and) all the other Western markets will be open between 2029 to 2033”, and that he expects Dr Reddy’s generic semaglutide to generate “hundreds of millions of dollars” in sales.

According to Reuters, other Indian drugmakers, including Cipla, Lupin, Biocon and Sun Pharma also plan to launch generic weight-loss drugs following the success of Novo Nordisk’s Wegovy® and Eli Lilly’s Mounjaro® (tirzepatide).

In October 2024, Novo Nordisk and each of Mylan Pharmaceuticals (a subsidiary of Viatris), Dr Reddy’s, Apotex and Sun Pharma settled their dispute regarding the validity of Novo Nordisk’s US patent no. 10,335,462 covering specific dosages of semaglutide used to treat type 2 diabetes.

On 24 July 2025, the Patent Trial and Appeal Board (PTAB) instituted an inter partes review (IPR), filed by Amgen in February 2025, challenging the validity of a BMS US patent (US11332529) relating to methods of treating colorectal cancer using nivolumab (Opdivo®) and ipilimumab (Yervoy®).

However, PTAB denied two further IPR petitions filed by Amgen at the same time in relation to patents for nivolumab/ipilimumab (US9856320 for treating cancer generally and US10174113 for treating melanoma) on the basis that the patents had been in force for 6 and 7 years respectively, creating strong settled expectations in patent protection for the patent owner.  PTAB held that similar expectations did not arise in relation to the instituted IPR as the subject patent had been in force for only 3 years.

Since Amgen’s IPR petitions were filed, the Opdivo®/Yervoy® combination has been approved for colorectal cancer in the US (April 2025) and Australia (June 2025), and for hepatocellular carcinoma in the EU (March 2025), US (April 2025), Japan (June 2025) and Korea (July 2025).

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development.  Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.  In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for an ipilimumab biosimilar.

On 23 July 2025, Biocon Biologics announced that it has launched Nepexto®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), in Australia.  Nepexto® was approved by Australia’s Therapeutic Goods Administration in September 2022, and will be supplied by Biocon’s local partner, Lupin (Generic Health).

In June 2025, we reported that Nepexto®, among other biosimilars, was positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).  Nepexto® became the second etanercept biosimilar to be PBS-listed as of 1 July 2025, following Samsung Bioepis/Arrow Pharma’s Brenzys® in April 2017.

In May 2022, Pfizer commenced Australian proceedings against Samsung Bioepis and other respondents (including MSD, Organon and Arrow Pharmaceuticals) for alleged infringement of its Australian patent AU2005280034 relating to the production of etanercept.  Samsung Bioepis and Organon cross-claimed, seeking to invalidate the patent.  The hearing is scheduled to commence on 1 September 2025.

Etanercept has been the subject of various lawsuits in the United States in recent years.  In May 2025, a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws in relation to Enbrel® (etanercept) (and Otezla® (apremilast)), awarding Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.

In April 2025, Sandoz announced that it filed an antitrust lawsuit in the US District Court for the Eastern District of Virginia, alleging that Amgen “unlawfully extended and entrenched its monopoly” for Enbrel® by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.  That litigation is ongoing.

On 23 July 2025, Fresenius Kabi announced that the European Commission (EC) has granted approval for Conexxence® and Bomyntra®, biosimilars to Prolia® and Xgeva® (denosumab), for all reference indications.

Conexxence® and Bomyntra® were recommended for approval at the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2025, alongside Sandoz’s second Prolia® biosimilar, Rolcya®.

Fresenius Kabi entered a global settlement with Amgen in respect of its denosumab biosimilars in March 2025.  The settlement resulted in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen against Fresenius in October 2024.  The global settlement permits European launch of Fresenius’ biosimilars at the end of November 2025.  Fresenius announced the US launch of Conexxence® and Bomyntra® on 1 July 2025.

There are now 7 sponsors with denosumab biosimilars approved in Europe, with previous approvals for Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025) and Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®,  Biocon’s Evfraxy® and Vevzuo® (July 2025).

Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted denosumab biosimilar MAAs including for Shanghai Henlius/Organon (HLX14, May 2024), Teva (TVB-009P, October 2024) and STADA/Alvotech (AVT03, October 2024).

On 23 July 2025, Janssen announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation (SC) as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma.  Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.

In November 2024, Janssen’s parent company, Johnson & Johnson, submitted its regulatory applications for the indication extension in the EU (Darzalex® SC) and in the US (Darzalex Faspro® SC, daratumumab and hyaluronidase-fihj).  The US FDA voted in favour (6-2) of Darzalex Faspro®’s benefit-risk profile in May 2025.

In July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44, to evaluate and compare the efficacy and safety of Darzalex® and CT-P44 over a two-year period in 486 patients with relapsed or refractory multiple myeloma.

Shanghai Henlius also has a daratumumab biosimilar in development, announcing in February 2025 that it entered into a licence agreement with Dr. Reddy’s for HLX15.  In June 2024, Henlius announced the completion of Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.

On 22 July 2025, Replimune announced that the FDA has advised it is unable to approve, in its present form, the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma. The FDA considers that the clinical trial relied on is not an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. The FDA also said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. However, no safety issues were raised.

Replimune submitted the BLA in November 2024 under the FDA’s Accelerated Approval pathway. The company says that the FDA’s issues were not raised during the mid- and late-cycle reviews, and that they had aligned on the design of the study, but will continue engage with the FDA to find a path forward for approval.

With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the information available to date in the clinicaltrials.gov registry:

• Samsung Bioepis (SB27): Ph 3 study to compare efficacy, safety, PK and immunogenicity between SB27 and Keytruda® in patients metastatic nsNSCLC initiated in April 2024. The study is currently recruiting with estimated primary completion in September 2025.
• Amgen (ABP 234): Ph 3 study in nsNSCLC initiated May 2024 to compare PK between ABP 234 and Keytruda® in patients with early-stage nsNSCLC as adjuvant treatment following resection and platinum-based chemotherapy. The study is currently recruiting, with estimated primary completion in March 2026.  Ph 3 study commenced in September 2024 to compare the efficacy, PK, safety and immunogenicity between ABP 234 and Keytruda® in patients with advanced or metastatic nsNSCLC.  The study is currently recruiting, with estimated primary completion in February 2028.
• Formycon (FYB206): Integrated Ph1/3 study commenced in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma. On 10 July 2025, Formycon announced that it had completed patient enrolment.  Formycon expects results to be available in Q1 2026.  Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC.  However, in February 2025, Formycon announced the premature termination of the Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.
• mAbxience (MB12): Ph 3 study to compare the PK, efficacy, safety and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic nsNSCLC. The study commenced in December 2024 and is currently recruiting, with estimated primary completion in June 2026.
• Sandoz (GME751): Ph 1 study commenced in May 2024 to compare PK of GME751 and Keytruda® in patients with stage II and III melanoma requiring adjuvant treatment with pembrolizumab. The study is currently recruiting with estimated primary completion in July 2026.  In April 2025, Sandoz announced it has “minimised” its Ph 3 trial in untreated metastatic nsNSCLC due to streamlining of FDA study requirements.
• Celltrion (CT-P51): Ph 3 trial plan approved by FDA in August 2024 with study initiated in January 2025 to compare efficacy and safety of CT-P51 and Keytruda® in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC. The study is currently recruiting with estimated primary completion in February 2027.
• Shanghai Henlius (HLX17): Integrated Ph 1/3 study initiated in April 2025 to evaluate the efficacy, safety, PK profile and immunogenicity of HLX17 vs Keytruda® in the first-line treatment of advanced nsNSCLC. The study is not yet recruiting, with estimated primary completion in April 2027.
• Bio-Thera (BAT3306): Ph 1/3 study commenced in July 2024 to evaluate the PK, efficacy and safety of BAT3306 plus chemotherapy versus Keytruda® plus chemotherapy in patients with stage IV nsNSCLC. The study is currently recruiting with estimated primary completion in July 2027.
• BioNTech (BNT327): Phase 2/3, Master Protocol for a Global Trial of BNT327 in combination with chemotherapy and other investigational agents in first-line NSCLC, initiated in January 2025. The study is currently recruiting, with estimated primary completion in December 2029.

On 21 July 2025, Samsung Bioepis published its US Biosimilar Market Report, which has been released every quarter since April 2023.  The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q3/2025 edition reports that, as of June 2025, the FDA has approved 75 biosimilars, with 52 of those launched.  On average, the ASP of biosimilars remained 20-30% lower than reference biologics, with increased discounts in crowded markets, such as those for adalimumab and ustekinumab.

The biosimilars US-approved in Q3 were Bio-Thera’s Starjemza® (ustekinumab, May 2025) and Biocon’s Jobevne^™ (bevacizumab, April 2025).  Biosimilars with US launches in Q3 were Sandoz’s Jubbonti® and Wyost® (denosumab, June 2025) and Samsung Bioepis/Teva’s Epysqli® (eculizumab, April 2025).

According to the Report, biosimilars in the US have gained an average of 52% market share within 5 years post initial launch.  However, some biosimilar markets have faster uptake speeds than others; in particular, oncology, ophthalmology and pegfilgrastim biosimilars reached an average of 81% market share 5 years post launch.

In a “Biosimilar Deep Dive”, the Samsung Bioepis Report considers potential implications of the US Government’s most favoured nation (MFN) policy on the US biosimilars market.  The MFN policy aims to reduce drug costs by ensuring access to the lower prices typically paid by similar nations.  The Report concludes that, although there remains uncertainty regarding MFN implementation, the policy may result in a smaller market, reducing commercial opportunities for biosimilars to enter and compete effectively and discouraging biosimilar manufacturers from investing in new products.

On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276) in India.  The injunction was granted in proceedings brought by BMS alleging Zydus’ Indian launch of its nivolumab biosimilar will infringe Indian patent no. 340060 (IN ’060).

The Court found that IN ‘060, which expires on 2 May 2026, covers BMS’ Opdivo® (nivolumab), sold as Opdyta® in India.  The Court also held that the patent’s validity was not sufficiently in doubt.  IN ‘060 had survived four pre-grant oppositions, filed by Indian Pharmaceutical Alliance (IPA), Pankaj Kumar Singh, Restech Pharmaceuticals and Dr. Reddy’s.  In addition, the validity of corresponding foreign patents had been upheld.  While IN ‘060 was currently facing a post-grant opposition filed by Zydus, that opposition had not yet been finalised.

As well as preventing launch before the patent’s expiry, the preliminary injunction prohibits the post-expiry sale of ZRCr-4276 manufactured before that expiry date.  Under Indian law, infringing goods manufactured during the term of a patent remain infringing after the patent expires.  Zydus has therefore been ordered to file an affidavit disclosing the quantity of biosimilar nivolumab it has already manufactured.

Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.  At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.

Zydus is no stranger to patent infringement proceedings in India, having faced patent infringement litigation brought by Roche in relation to its pertuzumab biosimilar.

In an article dated 18 July 2025, HiT News reported on a hearing in a patent infringement lawsuit filed by Regeneron and Bayer against Sam Chun Dang (SCD) and Optus Pharmaceutical in the Seoul Central District Court.  The lawsuit was filed by Regeneron/Bayer in January 2024 alleging that SCD’s licence agreement with an unnamed overseas company to supply its Eylea® (aflibercept, 2mg) biosimilar (SCD411) constituted infringement of Regeneron’s Korean Patent No. 659477.  Regeneron/Bayer are seeking damages based on the alleged infringement.

According to the article, at the hearing on 17 July 2025, the Court refused Regeneron/Bayer’s request for an order that SCD submit various documents and information, including the details of the licence agreement and other internal documents relating to that agreement.  SCD had objected to producing the documents on the basis that they were confidential and all contracts it entered in relation to biosimilar aflibercept were to take effect after expiry of the Korean patent.

The Court has reportedly narrowed the issues in dispute in the lawsuit to whether SCD’s entry into licence agreements before the expiry of the Korean patent constitutes patent infringement.  A further hearing has been scheduled for 11 September 2025.

In March 2024, it was reported that Sam Chun Dang had entered an exclusive distribution agreement with an unnamed distributor to supply its aflibercept biosimilar in the UK, Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland.  SCD’s biosimilar was also the subject of an exclusive distribution agreement reported in November 2023 with an unnamed distributor, for supply to Austria, Germany, Italy, Spain and Switzerland.  SCD reportedly licensed SCD411 to Apotex for the Canadian market in August 2023.

On 17 July 2025, Samsung Bioepis announced that it has entered into a licence, development and commercialisation agreement with eyecare pharmaceutical company, Harrow, in relation to Samsung Bioepis’ US ophthalmology portfolio.  The agreement follows Biogen’s October 2024 decision to terminate its November 2019 agreement with Samsung Bioepis, within the US and Canada, for commercialisation of Samsung Bioepis’ ophthalmology biosimilars.

Under the new agreement, Harrow will assume full commercial responsibility in the US for Samsung Bioepis’ Byooviz® (ranibizumab-nuna), biosimilar to Genentech’s Lucentis®, and Opuviz® (aflibercept-yszy), biosimilar to Regeneron’s Eylea®, upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.

Opuviz® was the first FDA approved interchangeable aflibercept biosimilar (with Biocon’s Yesafili™) in May 2024.  The US launch date for the product remains uncertain due to ongoing patent litigation brought by Regeneron against Samsung Bioepis (amongst others) regarding aflibercept.  A preliminary injunction was granted, and remains in place, preventing Opuviz®’s US launch (14 June 2024, upheld on appeal on 29 January 2025).

Byooviz® was FDA approved in September 2021, launched in the US on 2 June 2022 and approved as interchangeable to Lucentis® across all approved indications in October 2023.

On 16 July 2025, Celltrion announced the results of its global phase 3 trial comparing the efficacy and safety of its tocilizumab biosimilar, Avtozma® (CT-P47), to reference drug, Roche’s Actemra®.  The results demonstrated comparable efficacy, pharmacokinetics, safety and immunogenicity between patient groups that maintained the reference product and those that switched to Avtozma®.

Celltrion launched Avtozma® in Korea in June 2025, following its approval in December 2024 for the same indications as Actemra®.  Just days earlier, Australia’s Therapeutic Good’s Administration (TGA) approved Avtozma® as the first tocilizumab biosimilar in the country.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.  Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab).  BAT2506 is being developed and manufactured by Bio-Thera and will be commercialised in the US by Intas Pharmaceuticals’ subsidiary, Accord Biopharma, under a February 2025 agreement.

The BAT2506 BLA is the second BLA for a golimumab biosimilar to be accepted by the FDA, following acceptance of Alvotech/Teva’s BLA for AVT05 in January 2025, approval of which is expected in Q4 2025.

Accord’s BLA for BAT2506 requests approval for all currently approved indications of Simponi®, including the following treatments for adults: moderately to severely active rheumatoid arthritis (RA) (with methotrexate), active psoriatic arthritis (alone or with methotrexate), active ankylosing spondylitis and moderately to severely active ulcerative colitis.

Bio-Thera has entered commercialisation agreements for BAT2506 in jurisdictions outside the US, including with SteinCares for Latin America (March 2024), STADA in Europe, the UK and selected other countries (May 2024), and Dr Reddy’s for South East Asia (March 2025).

In February 2025, Bio-Thera/STADA’s European marketing authorisation application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA).  In November 2024, Alvotech/Advanz Pharma’s European marketing authorisation application for AVT05 was the first golimumab biosimilar MAA to be accepted anywhere in the world.

On 16 July 2025, the US District Court for the District of New Jersey made consent orders reflecting a settlement of the patent infringement litigation brought by Amgen against Accord and Intas relating to Accord/Intas’ biosimilar denosumab.  While the terms of the settlement agreement are confidential, the consent orders restrain Accord/Intas from launching biosimilar denosumab in the US until 1 October 2025.

Amgen commenced BPCIA proceedings against Accord/Intas in November 2024, alleging infringement of 34 of Amgen’s US patents relating to denosumab and methods of its manufacture.  The litigation followed Accord/Intas’ submission of an abbreviated Biologics Licence Application (aBLA) for INTP23, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

The proceeding against Accord/Intas was one of a number of proceedings that Amgen commenced in the US in relation to denosumab biosimilars, three of which have now settled.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, with Sandoz launching its denosumab biosimilars, Jubbonti® and Wyost®, in June 2025.  Fresenius Kabi launched Conexxence® and Bomyntra® in early July 2025, following a global settlement agreement with Amgen, resulting in the dismissal of US BPCIA litigation commenced by Amgen in October 2024.  Amgen and Celltrion also settled their BPCIA litigation in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025.

Amgen still has pending US denosumab litigation against Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.

On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®.

Kirsty™ (100 units/mL) will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple dose vial for subcutaneous and intravenous use.  It is indicated to improve glycaemic control in adults and paediatric patients with diabetes mellitus.  Kirsty™ has been available in Europe and Canada since 2022.

In February 2025, Sanofi-Aventis’ Merilog™/Merilog™ SoloStar were approved as the first US biosimilars to NovoLog®.  However, those products have not been granted interchangeability status.  There were also two long-acting insulin biosimilar products (insulin glargine) approved in 2021, Biocon/Mylan’s Semglee® and Eli Lilly’s Rezvoglar® (reference product: Sanofi’s Lantus®).

On 14 July 2025, Samsung Bioepis published a whitepaper entitled “Solving the Biosimilar Void in Europe”, which proposes various recommendations for European biosimilar policy reform.

The whitepaper states that the current biosimilar policy environment in Europe needs “improvements to better reflect the value recognition of biosimilars and ultimately support a more sustainable market”.  In particular, it identifies challenges that biosimilars face, with “restrictive and misaligned tailored Health Technology Assessment (HTA) and pricing and reimbursement (P&R) processes”; “tendering and cost-containment policies that lead to continuous price erosion” throughout the lifecycle of biosimilars; and polices that hinder sufficient uptake of biosimilars.

Against this background, Samsung Bioepis’ policy recommendations include the following:

• Tailoring and streamlining HTA for biosimilars (eg. taking into account additional benefits of biosimilars, HTA waivers, indication extrapolation and mechanisms for acceleration);
• Avoiding arbitrary price controls for biosimilars at launch (eg. unjustified mandatory discounts) and allowing price discounts to be achieved by market dynamics;
• Ensuring national, regional and local tenders support diversification of supply and fair competition through multi-winner tenders with contract volume shares; transparent and periodic tender opening and a broad set of value criteria considerations; and
• Implementing incentives to healthcare professionals to encourage prescribing and dispensing of biosimilars, based on shared decision making between physicians and patients

The whitepaper considers that “the most important step” is for “policymakers to shift from perceiving biosimilars solely as cost saving tools” and to recognise their “vital role in strengthening market efficiency, patient access and system resilience”.

On 11 July 2025, Ono Pharma announced that Korea’s Ministry of Food and Drug Safety has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first-line IV treatment of patients with unresectable or metastatic hepatocellular carcinoma.

The combination therapy has previously been approved for HCC in other jurisdictions including Japan (June 2025), the US (April 2025), and the EU (March 2025).

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development.  In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).

On 10 July 2025, Formycon announced that it has completed patient enrolment for its clinical study, “Dahlia”, which is comparing the pharmacokinetics, safety and tolerability of FYB206 (pembrolizumab) with MSD’s Keytruda® in malignant melanoma.  The study was commenced in June 2024 and has now enrolled a total of 96 participants.

Formycon had originally intended to conduct a parallel Phase 3 trial (“Lotus”) to compare the safety and efficacy of FYB206 with Keytruda® in non-small cell lung cancer (NSCLC).  However, in February 2025, Formycon announced the premature termination of the Phase 3 trial following communications with the US FDA and concluding that the trial was not necessary to obtain US approval of FYB206.

Formycon expects results of the study to be available in Q1 2026, with the earliest market entry of FYB206 being in 2029 for the US and after 2030 for the EU.

There are a number of other pembrolizumab biosimilars in clinical trials, including Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced in July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 commenced in May 2024).

In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17 and, in June 2025, Alvotech and Dr Reddy’s announced that they entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a pembrolizumab biosimilar.

On 9 July 2025, the Amsterdam District Court ruled that the Pharmaceutical Accountability Foundation (PAF) lacked standing in its collective claim against AbbVie regarding the sale of Humira® (adalimumab) in the Netherlands, finding that PAF did not hold the requisite interest in the claim.

PAF commenced proceedings against AbbVie in February 2023, alleging that AbbVie acted unlawfully by overcharging for Humira®, leading to the displacement of publicly insured health services and violating fundamental human rights under Article 2 of the European Convention on Human Rights, and further breached relevant competition laws by abusing its market power.

In a statement released on 9 July 2025, PAF says that it had estimated that AbbVie “earned as much as €1 billion in excess profit in the Netherlands, costing the health system an equivalent of 13,950 years of healthy life”, and that it was “disappointed that the court did not address the merits of [the] case”.  PAF is considering an appeal.

On 9 July 2025, Alvotech announced that it has acquired Switzerland-headquartered Ivers Lee Group to expand its capacity for assembly and packaging and support its growth plans.  According to Alvotech, the acquisition of Ivers Lee will provide “added flexibility and capacity to meet increased global demand” for Alvotech’s biosimilars, including the planned launch of three biosimilars in 2025.

This follows the June 2025 completion of Alvotech’s acquisition of Xbrane’s Swedish R&D operations and biosimilar to UCB’s Cimzia® (certolizumab pegol) in a US$28.9m deal.

Alvotech has also recently entered into a number of commercialisation agreements, including with Advanz Pharma in Europe in relation to AVT10, biosimilar to UCB’s Cimzia® (certolizumab pegol) (in July 2025) and canakinumab and ofatumumab biosimilars (in May 2025); and with Dr Reddy’s for the global development, manufacturing and commercialisation of a biosimilar to MSD’s Keytruda® (pembrolizumab) (in June 2025).

Alvotech’s AVT06, biosimilar to Bayer/Regeneron’s Eylea® (aflibercept, 2mg), received a positive CHMP opinion in June 2025 (it is to be commercialised in the EU by Advanz) and is expected to obtain US approval in Q4 2025 (Alvotech/Teva’s BLA having been accepted by the FDA in February 2025).  Alvotech/Teva’s Selarsdi® was the second biosimilar to J&J/Janssen’s Stelara® (ustekinumab) launched in the US in February 2025.

On 9 July 2025, Samsung Bioepis’ denosumab biosimilars, Ospomyv® and Xborso® (SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration (TGA), for all reference indications.

Samsung Bioepis is the third sponsor to obtain approval of denosumab biosimilars in Australia, following Sandoz’s Jubbonti® and Wyost® in August 2024 and Celltrion’s Stoboclo® and Osenvelt® in April 2025.

In December 2024, Sandoz’s denosumab biosimilars were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).  In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia.  In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

Samsung Bioepis’ denosumab biosimilars were approved in Europe and the US in February 2025 (as Obodence™ and Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings are ongoing.

On 9 July 2025, Lupin Limited and Zentiva Group announced that they have entered into a global licence and supply agreement for the commercialisation of Lupin’s certolizumab pegol biosimilar referencing UCB’s Cimzia®.

Under the agreement, Lupin is responsible for development, manufacturing and supply, with split responsibility for commercialisation: Lupin will commercialise in the US and Canada, with Zentiva in ROW, predominantly Europe and CIS markets.  Lupin will receive an initial payment of USD 10m and up to a further USD 50m on achievement of regulatory milestones, with profits from the defined markets to be shared by the companies.

Alvotech also has a certolizumab pegol biosimilar in development, AVT10, which it acquired from Xbrane in June 2025.  In early July 2025, Alvotech and Advanz Pharma entered a European supply and commercialisation agreement for AVT10.

On 8 July 2025, Celltrion announced the US launch of Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.  Celltrion is the third sponsor to launch denosumab biosimilars in the US, following Sandoz’s launch of Jubbonti® and Wyost® in June 2025 and the announcement of Fresenius Kabi’s launch of Conexxence® and Bomyntra® on 1 July 2025.

Celltrion secured FDA approval for its denosumab biosimilars in March 2025, following submission of its abbreviated Biologics Licence Application in December 2023.  In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation was settled in January 2025, allowing Celltrion to launch its denosumab biosimilars in the US from 1 June 2025.

Samsung Bioepis is the only other sponsor with denosumab biosimilars approved in the US (Ospomyv™ and Xbryk™, approved February 2025), but it has not yet launched the products.  BPCIA litigation commenced by Amgen against Samsung Bioepis regarding its denosumab biosimilars remains pending.

Amgen also has pending US BPCIA litigation against Accord/Intas, Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.

On 7 July 2025, Biocon announced that it has received marketing authorisations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its denosumab products Evfraxy® and Vevzuo®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, across all indications of the reference products.

Biocon is the fifth sponsor to have received marketing authorisation for its denosumab biosimilars in the UK, following Sandoz’s Wyost® and Jubbonti® (November 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (March 2025), Celltrion’s Stoboclo® and Osenvelt® (May 2025) and Accord’s Osvyrti® (June 2025).

The UK approval of Evfraxy® and Vevzuo® comes a week after Biocon received EU approval for them.

On 4 July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab).  The trial will evaluate and compare the efficacy and safety of Darzalex® and CT-P44 over a two-year period in 486 patients with relapsed or refractory multiple myeloma.

In December 2024, Celltrion announced that the US FDA approved its IND application for a global Phase 3 clinical trial of CT-P44, which followed its European IND submission and entry into the global Phase 3 trial in November 2024.

Shanghai Henlius has a daratumumab biosimilar in development, announcing in February 2025 that it entered into a licence agreement with Dr. Reddy’s for HLX15.  In June 2024, Henlius announced the completion of Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.

Over the last week, the European Commission (EC) has approved denosumab biosimilars for three sponsors:

• Gedeon Richter’s Junod® and Yaxwer® (announced 1 July 2025);
• mAbxience’s Izamby® and Denbrayce® (announced 2 July 2025); and
• Biocon’s Evfraxy® and Vevzuo® (announced 3 July 2025).

The biosimilars all received positive CHMP opinions in April 2025.

Richter’s and Biocon’s denosumab biosimilars are approved for the same indications as Amgen’s Prolia® and Xgeva®, respectively.  mAbxience’s Izamby® is approved for one of Prolia®’s indications (treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures), while the indications for Denbrayce® mirror those of Xgeva®.

There are now 6 sponsors with denosumab biosimilars approved in Europe, with previous approvals for Celltrion’s Stoboclo® and Osenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted denosumab biosimilar MAAs including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

On 2 July 2025, The Economic Times reported that Aurobindo Pharma’s wholly owned subsidiary, CuraTeq Biologics, has received marketing approval from the European Commission for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).  The authorisation follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) of Dazublys® for the treatment of HER2-positive breast or gastric cancers.

Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017), while Mylan/Biocon’s Ogivri® was the first to be approved in the US (December 2017).

On 2 July 2025, Sunshine Biopharma announced that its wholly owned Canadian subsidiary, Nora Pharma, has launched Niopeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in Canada.  Niopeg® was approved by Health Canada in April 2024 in pre-filled syringe of 6mg/0.6 ml.

The first pegfilgrastim biosimilar approved in Canada was Apotex’s Lapegla® in June 2018.  Shortly after, Mylan/Biocon’s Fulphila® (pegfilgrastim) was approved in the US (June 2018) and Accord Healthcare’s Pelgraz (pegfilgrastim) was approved in the EU (September 2018).

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth €411 million coordinated by the Instituto Nacional de Gestión Sanitaria (INGESA).

According to the report, this second-phase agreement builds upon the initial framework launched in late 2022, which generated over €120 million in cost savings to date.  The new agreement is expected to deliver an additional €178 million in savings and will comprise 17 therapeutic categories covering biologics that have approved biosimilars.  The Framework Agreement includes the following biologics, among others: adalimumab, etanercept, infliximab, rituximab, trastuzumab, pegfilgrastim, bevacizumab, tocilizumab, natalizumab, eculizumab, ranibizumab and ustekinumab.

INGESA will select between 25 and 50 suppliers using an open procedure, with contracts awarded based on 70% price and 30% quality weighting.

On 2 July 2025, Apotex announced that Aflivu™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), has been approved by Health Canada in pre-filled syringe and vial formats.  Aflivu™ is indicated for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation.

In August 2023, it was reported that Sam Chun Dang Pharm licensed its aflibercept biosimilar, SCD411, to Apotex for Canada.  Apotex’s announcement regarding the approval of Aflivu™ does not indicate whether this is the Sam Chun Dang developed biosimilar.  However, Sam Chun Dang announced on 2 July 2025 that SCD411 received product approval from the Canadian Ministry of Health on 26 June 2025 and that sales will commence in July 2025.

The announcements from Apotex and Sam Chun Dang follow closely behind the June approval of Biocon’s Yesafili™, which was reported to be the first aflibercept biosimilar approved in Canada.  Yesafili™ was due to be launched in Canada on 4 July 2025, as a result of a March 2024 settlement between Biocon and Regeneron/Bayer.

The only aflibercept biosimilar currently available in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).

While there are a number of aflibercept biosimilars approved in Europe, there have been no announcements to date that any of them have launched, although Sandoz has indicated that the European launch of its biosimilar, Afqlir® (EU-approved in November 2024), is expected in Q4 2025.  In Australia, Regeneron and Bayer have commenced court proceedings against Sandoz, seeking to prevent the Australian launch of Afqlir®, scheduled for December 2025.

On 1 July 2025, Sandoz announced that it has commenced construction of a new biosimilar production centre in Brnik, Slovenia, due to open in 2028.  Sandoz is investing USD 440 million in the project, which is intended to expand Sandoz’s European biosimilar hub and increase its global market reach.

The new facility will focus on the production of injectable products for Sandoz’s existing and upcoming portfolio of biosimilars and will include preparation, filling, assembly and packaging of sterile injectable products, together with laboratories for quality control.

The project will bring Sandoz’s total planned investment in Slovenia to more than USD 1.1 billion by 2029, with the company previously investing in a biosimilar drug substance centre in Lendava and a biosimilar development centre in Ljubljana.

Sandoz recently launched the first denosumab biosimilars on the US market (Jubbonti® and Wyost®, 2 June 2025) and launched biosimilar ustekinumab in the US in February 2025 (Pyzchiva®, developed by Samsung Bioepis, EU launch in July 2024).  Sandoz currently has a number of biosimilars under development, including nivolumab, ipilimumab, pembrolizumab and ocrelizumab.

On 1 July 2025, Formycon announced that Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s FYB201, biosimilar to Genentech’s Lucentis® (ranibizumab), has entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd.  The partnership gives Bio Usawa the exclusive rights to commercialise FYB201 under the brand name BioUcenta™ in Sub-Saharan Africa.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics).  It has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (marketed as Ravegza® by MS Pharma).

Last month, Brazil’s ANVISA had granted marketing authorisation for Ranivisio® (FYB201), with an expected launch in Q4 2025 by Formycon’s commercialisation partner, Biomm, and then a phased market rollout of Ranivisio® across Latin America.  Marketing authorisations have previously been granted in Peru, El Salvador, Honduras and the Dominican Republic and further approvals in Central and South America are planned.

On 1 July 2025, Pharma Japan reported that Celltrion will launch Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan on 8 July 2025.

Celltrion’s biosimilar ustekinumab launch follows Alvotech/Fuji Pharma’s launch of AVTO4 (ustekinumab) in May 2024 and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, launched in May 2025.

Samsung Bioepis may be next in line, following its announcement on 9 June 2025 that it had entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ ustekinumab biosimilar.

Celltrion’s Steqeyma® was launched in the US in March 2025 and in the EU in November 2024.

On 1 July 2025, Fresenius Kabi announced the US launch of Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.  Fresenius’ denosumab biosimilars are the second to launch in the US, following the 2 June 2025 launch of Sandoz’s Wyost® and Jubbonti®.

The launch of Conexxence® and Bomyntra® follows a global settlement agreement between Fresenius Kabi and Amgen, resulting in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen in October 2024.  The global settlement permits European launch of the products “later in H2 of 2025”, subject to regulatory approvals.  The US launch of Sandoz’s denosumab biosimilars similarly followed a settlement of US patent litigation commenced by Amgen.

There are currently two other sponsors with denosumab biosimilars approved in the US, which have not yet launched: Celltrion (Stoboclo® and Osenvelt®, approved March 2025), and Samsung Bioepis (Ospomyv™ and Xbryk™, approved February 2025). Amgen settled denosumab patent litigation against Celltrion in January 2025, permitting US launch of Celltrion’s Stoboclo® and Osenvelt® from 1 June 2025 (although launch has not yet occurred).  BPCIA litigation commenced by Amgen against Samsung Bioepis regarding denosumab biosimilars remains pending.

Amgen also has pending US BPCIA litigation against Samsung Bioepis, Accord/Intas, Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.

On 1 July 2025, Samsung Bioepis and Hanmi Pharmaceutical announced that they have jointly launched Obodence™, biosimilar to Amgen’s Prolia® (denosumab), in South Korea, at a 13% cost savings to patients compared to the reference product.  This follows Korean approval of Obodence™ in April 2025.

On 2 July 2025, Samsung Bioepis also announced that it has entered into an exclusive licensing deal with Boryung to market its other denosumab biosimilar, Xbryk™ (biosimilar to Amgen’s Xgeva®) in South Korea.  Xbryk™ received Korean approval in May 2025.

Celltrion’s Stoboclo® and Osenvelt™ were the first denosumab biosimilars to be approved in Korea (November 2024).  In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.

On 1 July 2025, Alvotech and Advanz Pharma announced that the companies have entered into a European supply and commercialisation agreement for AVT10, Alvotech’s biosimilar to UCB’s Cimzia® (certolizumab pegol).

The announcement follows Alvotech’s acquisition of Xbrane’s biosimilar certolizumab pegol in June 2025, together with Xbrane’s Swedish R&D operations.

Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for commercialisation of certain biosimilars in Europe and certain other countries, including AVT23 (biosimilar to Novartis’ Xolair® (omalizumab)), AVT05 (biosimilar to Janssen’s Simponi® and Simponi Aria® (golimumab)), AVT16 (biosimilar to Takeda’s Entyvio® (vedolizumab)), AVT06 and AVT29 (biosimilars to Regeneron’s Eylea® (aflibercept) in low (2mg) and high (8mg) doses, respectively), and biosimilars to Sanofi/Regeneron’s Dupixent® (dupilumab), Eli Lily’s Taltz® (ixekizumab) and J&J/Janssen’s Tremfya® (guselkumab).  In May 2025, the companies expanded their partnership to include biosimilars to Novartis’ Ilaris® (canakinumab) and Kesimpta® (ofatumumab).

On 1 July 2025, Kexing Biopharm announced via LinkedIn that Pakistan’s Drug Regulatory Authority has granted marketing approval to Arketin™, biosimilar to Roche/Genetech’s Avastin® (bevacizumab).

Arketin™ (marketed as Pusintin® in other regions) was developed by TOT BIOPHARM and is subject to an exclusive commercialisation agreement entered into with Kexing Biopharm in January 2022.  Pusintin® was approved in China in December 2021.

On 30 June 2025, Amgen filed BPCIA litigation against Biocon in the in the US District Court for the District of Massachusetts, Eastern Division, asserting infringement of 34 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.

The litigation follows Biocon’s submission of a Biologics Licence Application to the FDA for Bmab 1000, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

The filing of the Biocon Complaint means Amgen now has five US proceedings pending regarding denosumab biosimilars, with litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon commenced on 25 June 2025 and proceedings against Accord/Intas and Samsung Bioepis commenced in November 2024 and August 2024, respectively.

Amgen has settled three other US denosumab disputes over the last 18 months.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, in the US from 31 May 2025.  Jubbonti® and Wyost® were launched in the US on 2 June 2025.  Amgen settled its US litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025 (although launch has not yet occurred).  In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025.

The results of a phase I study published in Annals of Medicine is said to have established biosimilarity between Beijing SL Pharmaceuticals’ pertuzumab biosimilar, KM118, and the reference product, Roche’s Perjeta®.

Roche has previously claimed it is unconcerned about biosimilar pertuzumab products despite pertuzumab biosimilars being considered for approval in China, Europe and the USA (all by Henlius), and approved in India (Zydus and Intas) and Russia (Biocad).

On 27 June 2025, Bayer announced that the European Commission has granted a label extension for Eylea™ 8mg (aflibercept, 114.3mg/ml solution for injection) with extended treatment intervals of up to 6 months for the treatment of nAMD and visual impairment due to diabetic macular oedema (DME).

This news comes just over a month after the label extension was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2025.

Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea™ in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 60 markets for the treatment of nAMD and DME.  Regeneron/Bayer have recently submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following retinal vein occlusion (RVO) in Japan (May 2025), Europe (April 2025) and the US (application accepted by FDA for priority review in April 2025, with a target action date of 19 August 2025).

On 27 June 2025, Biocon Biologics announced that Yesafili™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg) has been approved by Health Canada in vial and PFS presentations, becoming the first aflibercept biosimilar approved in Canada.  It is indicated for nAMD, visual impairment due to macular oedema secondary to RVO, diabetic macular oedema (DME) and myopic CNV.

The Canadian launch of Yesafili™ is planned for 4 July 2025, as a result of a March 2024 settlement between Biocon and Regeneron/Bayer.  The July 2025 Canadian launch will be the first launch of Yesafili™ worldwide.  Amgen’s Pavblu™ (aflibercept) was launched in the US in October 2024.

Yesafili™ was the first aflibercept biosimilar approved in Europe in September 2023 (where it is not yet launched).  In the US, both Yesafili™ and Samsung Bioepis’ Opuviz®, were the first approved interchangeable aflibercept biosimilars in May 2024.  Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026, or earlier under certain undisclosed circumstances.

On 26 June 2025, Formycon announced that it has entered into a non-exclusive distribution agreement with Teva Group’s subsidiary, Ratiopharm GmbH, to commercialise FYB202/Fymskina®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Germany.  German launch of Fymskina® is planned for Q3 2025.

Under the agreement, which follows the European Commission’s approval of Fymskina®/FYB202 in September 2024, Formycon is responsible for manufacture and supply, and Ratiopharm is responsible for commercialisation.

Formycon entered into a global commercialisation partnership for FYB202 with Fresenius Kabi in February 2023, in which Formycon retained secondary commercialisation rights for Germany, parts of Latin America, and the MENA region.  Pursuant to the global commercialisation agreement, Formycon and Fresenius Kabi launched FYB202 (marketed as Otulfi®) in Canada in May 2025 and in the US in March 2025 (securing US interchangeability for FYB202 in May 2025).  Formycon also separately entered into a licence/supply agreement with MS Pharma for countries in the MENA region in December 2024.

On 26 June 2025, New Zealand Doctor reported that Novo Nordisk is set to launch Wegovy® (semaglutide) in New Zealand from 1 July 2025.

New Zealand’s Medsafe approved Wegovy® in March 2025 for two indications:

• an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults and adolescents aged 12 years and above; and
• as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in adults with established cardiovascular disease (CVD) without established Type 1 or Type 2 diabetes.

Semaglutide was first approved in New Zealand as Ozempic® in March 2023, indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

Wegovy® was launched in Australia in August 2024, following its approval in September 2022 for weight management.  In December 2024, Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® to reduce the risk of MACE in overweight and obese adults with established CVD and without established Type 1 or Type 2 diabetes.

On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma Pharmaceuticals/Gedeon Richter and Shanghai Henlius Biotech/Organon, asserting infringement of multiple US patents (32 for Hikma/Richter and 26 for Henlius/Organon) covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.

The litigation follows the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab).  Under an exclusive licence agreement entered in December 2021, Gedeon Richter is responsible for the development of RGB-14, while Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US following approval.

Organon and Shanghai Helius’ BLA for HLX14 (denosumab) was accepted for review by the FDA in October 2024.  In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab, HLX11) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

The complaints against Hikma/Richter and Henlius/Organon represent the 6^th and 7^th BPCIA suits filed by Amgen in the US in relation to alleged patent infringement concerning denosumab biosimilars.  However, Amgen has settled three of its US denosumab disputes over the last 18 months.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, in the US from 31 May 2025.  Amgen settled its US litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025.  In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025.  Amgen’s BPCIA litigation against Accord/Intas and Samsung Bioepis regarding their denosumab biosimilars remains pending.

On 25 June 2025, Bio-Thera Solutions, Ltd. and Costa Rican-based SteinCares announced that they have signed an agreement to commercialise biosimilar dupilumab across Latin America.  Under the agreement, Bio-Thera will be responsible for product development and supply, while SteinCares will lead the registration and commercialisation process throughout Latin America.

Bio-Thera’s BAT2406, biosimilar to Sanofi’s Dupixent® (dupilumab), is currently undergoing Phase I clinical trials.

This is the fourth product on which the companies have agreed to collaborate in the region.  An agreement was announced in March 2024 in relation to BAT2606, biosimilar to GSK’s Nucala® (mepolizumab) and BAT2506, biosimilar to J&J’s Simponi® and Simponi Aria® (golimumab).  The partnership was expanded in December 2024 to include a third undisclosed product.

On 25 June 2025, Formycon announced that Klinge Biopharma, its exclusive global licensee of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2 mg), has entered an exclusive licence agreement with Valorum Biologics for commercialisation of FYB203 in the US and Canada.

Under the agreement, Klinge will receive royalties on net sales and is eligible to receive upfront and milestone payments, with Formycon receiving a single to low double-digit percentage of those payment streams.  Formycon will additionally receive service payments and a volume-based profit component for organising the commercial market supply on behalf of Klinge.

FYB203 was approved in the US in June 2024, where it is currently subject to a preliminary injunction granted in June 2024, and upheld at the end of January 2025, resulting from a patent infringement proceeding brought by Regeneron in November 2023.

The only aflibercept biosimilar to have launched in the US is Amgen’s Pavblu™, which launched in October 2024 following the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (June 2025), which is pending.

Formycon developed FYB203 and Klinge holds the exclusive global commercialisation rights.  In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 in Europe (excluding Italy) and Israel.  FYB203 received approval from the European Medicines Agency (EMA) in January 2025, under the brand names Ahzantive® and Baiama®, and from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025.

In May 2024, Valorum partnered with Xbrane and STADA in relation to their ranibizumab biosimilar, which has not yet been approved in the US.

On 24 June 2025, Biocon Biologics announced it has partnered with the National Cancer Society of Malaysia (NCSM), a non-for-profit organisation, to launch a Patient Assistance Program advocating for the accessibility and affordability of biosimilars.  Biocon intends to supply the NCSM with a range of biosimilars from its oncology portfolio, including trastuzumab, pegfilgrastim and bevacizumab.  The program will commence with provision of bTrastuzumab to cancer patients currently facing treatment delays due to budget constraints.

In the US, Biocon’s oncology franchise includes Ogivri® (biosimilar trastuzumab, launched in December 2019), Fulphila® (biosimilar pegfilgrastim, approved June 2018) and Jobevne™ (biosimilar bevacizumab, approved April 2025).

On 24 June 2025, Ono Pharmaceutical and BMS announced that they have received a supplemental approval for expanded use of Ono’s Opdivo® (nivolumab) and BMS’ Yervoy® (ipilimumab) in combination for the treatment of unresectable hepatocellular carcinoma (HCC).  The approval comes almost a year after the companies submitted the supplemental application in August 2024.

The combination therapy has previously been approved for HCC in the US (April 2025) and EU (March 2025) and remains under consideration in Australia.  In May 2025, Australia’s Therapeutic Goods Administration (TGA) approved the combination therapy for unresectable or metastatic colorectal cancer (CRC), and it was recommended for PBS-listing for stage III melanoma in June 2025.

On 23 June 2025, Alvotech and Advanz Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).

AVT06 is indicated for the treatment of adults with nAMD, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Alvotech and Advanz Pharma entered into an agreement in relation to the European commercialisation of AVT06 in June 2024.  Under the agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive.  The agreement also covers Alvotech’s AVT29, biosimilar to high-dose (8mg) Eylea®.

There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025).

Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025.  A number of aflibercept (2mg) biosimilars are also awaiting European Commission approval, including STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli® (positive CHMP opinions adopted in June 2025).

In February 2025, Alvotech’s AVT06 BLA was accepted in the US, where it is to be commercialised by Teva.  Alvotech and Teva are expecting that regulatory approval from the FDA will be obtained in Q4 2025.

On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders.  Regeneron is seeking both an interlocutory injunction and final relief.

The first case management hearing in the proceeding was held on 23 June 2025, with Sandoz publicly confirming that it intends to PBS-list and launch Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in Australia from 1 December 2025.  Sandoz does not presently intend to exploit its other ARTG-listed aflibercept biosimilar, Enzeevu®, in Australia during 2025.

Sandoz indicated at the case management hearing that it will be filing a cross-claim seeking to invalidate the AU599 patent, including for lack of novelty.

The hearing of Regeneron/Bayer’s interlocutory injunction application is scheduled for 14 August 2025.

On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®.

Samsung Bioepis is not the first to offer an unbranded US adalimumab biosimilar, with the FDA approving Celltrion’s sBLA for unbranded Yuflyma® (adalimumab-aaty) in November 2023.

In May 2025, the FDA expanded interchangeability for Samsung Bioepis’ Hadlima® in high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe.  In the same month, the FDA also granted Celltrion’s Yuflyma® expanded interchangeability to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations.  According to the companies, both biosimilars are now fully interchangeable with AbbVie’s Humira®.

The first high-concentration biosimilar to AbbVie’s Humira® to receive an interchangeability designation was Alvotech and Teva’s Simlandi®, which was approved in February 2024.

Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®), Viatris’ Nepexto® (etanercept, biosimilar to Pfizer’s Enbrel®), Sandoz’s Tyruko® (natalizumab, biosimilar to Biogen’s Tysabri®).

Celltrion’s Steqeyma® is set to become the first biosimilar to Janssen’s Stelara® (ustekinumab) to be listed on the PBS.  The product has reached the final “government processes” stage, indicating that PBS-listing is imminent.  Steqeyma® was recommended in December 2024 following its consideration at PBAC’s November 2024 meeting.  Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for listing at the March 2024 PBAC meeting, however Amgen is not proceeding with the PBS-listing and the PBAC process has ceased.  Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting, but remains in the earlier stages of application.

Viatris’ Nepexto® may soon become the second biosimilar to Pfizer’s Enbrel® (etanercept) subsidised under the PBS, also reaching the final “government processes” stage.  Samsung Bioepis/Arrow Pharma’s Brenzys® was the first PBS-listed etanercept biosimilar in April 2017.

Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), is also approaching PBS listing, following its recommendation in PBAC’s March 2025 meeting and approval as the first and only natalizumab biosimilar in Australia (April 2025).  Tyruko® was developed by Polpharma Biologics and, under a global commercialisation agreement with Sandoz reached in 2019, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) recommended for reimbursement for stage III melanoma and Novartis’ Xolair® (omalizumab) recommended for reimbursement for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).

In July 2024, Zydus Life Sciences’ nivolumab biosimilar received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer.  At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.  On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for a biosimilar to BMS’ Yervoy® (ipilimumab).

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia (November 2024), and was recommended for reimbursement at PBAC’s March 2025 meeting, though has not yet proceeded to PBS-listing.  However, Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab.

STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), were each recommended (as 40 mg/ml solution for injection in pre-filled syringes and vials) for treatment of nAMD and visual impairment due to macular oedema secondary to retinal vein occlusion/diabetic macular oedema (DME)/myopic choroidal neovascularisation.

There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025).  Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025.

Bio-Thera Solution’s Usymro® (BAT2206), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) also received a positive CHMP opinion, for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease.  Bio-Thera and Gedeon Richter entered into a licence and commercialisation agreement for Usymro®/BAT2206 in October 2024, under which Bio-Thera is responsible for the development and manufacturing of the product while Richter has commercialisation rights for the EU, UK and Switzerland.  BAT2206 was approved in the US in May 2025 where it is to be commercialised by Hikma Pharmaceuticals under the name Starjemza®.

A sixth biosimilar recommended by the CHMP at its June meeting was Biocon’s Vivlipeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim), to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.  The recommendation comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicine registrations to include expanded indications for BMS’ Opdivo® (nivolumab) and Winglore™ (ipilimumab) in combination for the treatment of adult patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a validated test.  The indication extensions were registered by the TGA on 16 and 19 May 2025, respectively.

The combination therapy for the same indication has been approved in the US (April 2025) and EU (December 2024), and was recommended for NHS funding in the UK (April 2025).

In July 2024, Zydus Life Sciences’ nivolumab biosimilar received approval from India’s Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), for locally advanced or metastatic non-small cell lung cancer.  At least Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars under development.  On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced that they entered into a global collaboration agreement to commercialise a biosimilar of BMS’ Yervoy® (ipilimumab).

On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary injunctions against Amgen and Samsung Bioepis in relation to the sale of their eculizumab biosimilars in the EU.  The result is that Amgen and Samsung Bioepis are free to continue selling their eculizumab biosimilars in the EU.

Alexion had originally filed the proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking preliminary injunctions for alleged infringement of EP 3 167 888 (method of treating paroxysmal nocturnal hemoglobinuria).  On 20 December 2024, the UPC Court of Appeal denied Alexion preliminary injunctions, upholding the earlier decisions of the Hamburg Local Division of the UPC, delivered on 26 June 2024

The UPC Court of Appeal refused Alexion’s rehearing applications on the basis that Alexion had not established that there was a fundamental procedural defect in the earlier decisions of the Court of Appeal.

Samsung Bioepis’ Epysqli® (SB12), biosimilar to Alexion’s Soliris® (eculizumab), was approved by the European Medicines Agency (EMA) on 30 May 2023 and was launched in Europe in 2023.  Amgen’s Bekemv® (eculizumab) was EMA approved in April 2023.

On 21 May 2025, Mr Justice Meade of the High Court of Justice for England and Wales delivered his decision in proceedings involving allegations of patent infringement by Alexion against each of Samsung Bioepis and Amgen, finding Alexion’s asserted patent (European Patent (UK) No. 3 167 888 B1) to be not infringed and invalid.

Samsung Bioepis and Amgen have both filed post-grant oppositions to Alexion’s EP 3 167 888.  Those oppositions are ongoing.

On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for March, April and May 2025.

Among the applications to be reviewed is MSD’s clesrovimab (MK-1654, approved on 9 June 2025 as Enflonsia™ in the US; brand name yet to be confirmed in Australia) for the prevention of respiratory syncytial virus (RSV) in newborns and infants who are born during or entering their first RSV season.  Clesrovimab has not yet been approved for any indication in Australia.

The TGA will also review an indication expansion for GSK’s Nucala® (mepolizumab) as an additional treatment for adults with chronic obstructive pulmonary disease (COPD).  This indication was approved by the US FDA in May 2025, with corresponding applications being accepted by the European Medicines Agency (March 2025) and China’s National Medical Products Administration (February 2024).

Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Phase 1 trials (according to the company’s pipeline), and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the marketing rights of the drug across Latin America.

On 17 June 2025, Regeneron filed a new BPCIA complaint against Amgen in the United States District Court for the Central District of California, asserting that Amgen’s Pavblu™/ABP 938 (aflibercept) infringes US 12,331,099, which claims an ophthalmic formulation of aflibercept.  The US 099 patent was granted on the same date that Regeneron’s complaint was filed.

Regeneron is seeking an injunction preventing Amgen from infringing the US 099 patent, including by selling and distributing Pavblu™, damages in the form of lost profits, additional damages for wilful infringement and legal costs.

The new complaint follows the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen’s Pavblu™ in October 2024 in respect of another of Regeneron’s US formulation patents (US Patent No. 11,084,865).  In the earlier case, the Appeals Court determined that the relevant claims of the US 865 patent required an aflibercept formulation that included a separate buffer component, but Amgen’s formulation did not contain any such buffer.

Amgen’s Pavblu™, biosimilar to Regeneron’s Eylea® (aflibercept), was approved in August 2024 and launched in the US in October 2024 following the Court of Appeals’ decision.

Regeneron is seeking that the new complaint against Amgen be consolidated with its other pending aflibercept BPCIA litigation against each of Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024).  Preliminary injunctions were granted, and remain in place, preventing biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).

Regeneron settled US BPCIA litigation regarding aflibercept with Biocon in April 2025, paving the way for a US launch of Biocon’s biosimilar, Yesafili™ (approved May 2024) in the second half of 2026, or earlier under certain undisclosed circumstances.

Samsung Bioepis, Formycon and Celltrion have been challenging the validity of Regeneron’s US 11,084,865 before the USPTO, having each filed a petition for IPR (inter partes review) in November 2024, December 2024 and January 2025, respectively.  On 2 June 2025, the PTAB denied institution of Samsung Bioepis’ and Formycon’s petitions including because the ‘865 patent is already the subject of the pending BPCIA litigation.  Celltrion’s petition remains pending.

On 16 June 2025, Celltrion announced that the FDA has approved a new single-dose 45mg/0.5mL subcutaneous injection of Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The new presentation is approved for the treatment of paediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis or psoriatic arthritis.  The FDA has also granted Steqeyma® full interchangeability with Stelara® across all its indications.

Steqeyma® was first approved by the FDA in December 2024 in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and paediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis.  Celltrion launched Steqeyma® in the US in these presentations in March 2025.

Amgen’s Wezlana® was the first ustekinumab biosimilar to be approved as interchangeable with Stelara® in the US in October 2023, followed by Alvotech/Teva’s Selarsdi® and Formycon/Fresenius’ FYB202/Otulfi®, both in May 2025.

There are a number of ustekinumab biosimilars now launched in the US including Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), and Formycon/Fresenius Kabi’s Otulfi® (Mar 2025).

On 16 June 2025, Korea Biomedical Review reported that the Dusseldorf Higher Regional Court ruled that Samsung Bioepis/Biogen’s Imraldi®, biosimilar to AbbVie’s Humira® (adalimumab), infringes a formulation patent held in Germany by Fresenius Kabi.  The Fresenius patent,  EP 3 145 488 B1, claims a liquid pharmaceutical composition consisting of 50 mg/mL adalimumab, a citrate buffering system, sugar stabiliser, tonicifier and surfactant in a certain molar ratio.

In overturning a 2022 decision of the Dusseldorf Regional Court, the Higher Court granted an injunction preventing Biogen’s sales of Imraldi® in Germany and ordering Biogen to recall and destroy existing inventory and to pay damages in an amount to be determined.

An opposition to the EP ‘488 patent in the European Patent Office by Samsung Bioepis and Biogen was rejected on 20 June 2024 by the Technical Board of Appeal.

Imraldi® received European regulatory approval in 2017 and was launched in Europe in October 2018 under a licence from AbbVie entered into in April 2018.  It is known as Hadlima® in the US, where it is commercialised by Organon (approved July 2019, launched in July 2023).

Fresenius Kabi’s citrate-free adalimumab biosimilar, Idacio® was approved in Europe in 2019 and in the US in December 2022.  It was launched in Europe in 2019 and in the US in July 2023.

On 12 June 2025, Celltrion, Amgen and Pfizer each received FDA approval of an additional indication for their rituximab biosimilars (Truxima®, Riabni® and Ruxience®, respectively), for treatment of moderate to severe pemphigus vulgaris in adult patients.

With the new indication, Amgen’s Riabni® is now approved for all indications of Genentech/Biogen’s Rituxan®, while Celltrion’s Truxima® is approved for all of Rituxan®’s non-paediatric indications.  Pfizer’s Ruxience® is the only biosimilar without full adult coverage, missing both chronic lymphocytic leukemia and rheumatoid arthritis.

Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997.  Truxima®, Riabni® and Ruxience® are currently the only three rituximab biosimilars approved in the US market, with Dr Reddy’s rituximab biosimilar being knocked back by the FDA in April 2024.

On 12 June 2025, the US FDA announced that it has approved MSD’s Keytruda® (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 as determined by an FDA-approved test.  Keytruda® is approved as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin after surgery, and then as a single agent.  The approval comes in advance of the 23 June 2025 target action date assigned when the sBLA was accepted by the FDA for priority review in February 2025.

The FDA’s review of MSD’s sBLA was conducted under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners.  Keytruda® is currently under evaluation in Australia for the same HNSCC indication and regulatory authorities in Brazil, Canada, Israel and Switzerland are also reviewing the application.

The new indication approval comes days after it was reported by Fierce Pharma that the FDA has narrowed the label for Keytruda® (and Opdivo® (nivolumab)) in gastric, gastroesophageal junction and oesophageal cancers to only those patients whose tumours express PD-L1.  The limitation for Keytruda® applies to HER2-negative disease as the indication relating to HER2-positive disease had already been limited to PD-L1 positive tumours in November 2023.

On 11 June 2025, Sweden-based Xbrane Biopharma and OneSource Specialty Pharma, an Indian-based CDMO, announced that they have entered a partnership for the commercial manufacture of Xbrane’s biosimilar portfolio.

Xbrane’s biosimilars include Ximluci®, biosimilar to Genentech’s Lucentis® (ranibizumab), which was launched by Xbrane and STADA in Europe in April 2023.  On 21 April 2024, the FDA issued a Complete Letter Response regarding Xbrane’s ranibizumab BLA.  Xbrane resubmitted its BLA to the FDA in December 2024.

The manufacturing partnership between Xbrane and OneSource closely follows completion of Alvotech’s acquisition of Xbrane’s Swedish R&D operations, as well as XB003, biosimilar to UCB’s Cimzia® (certolizumab pegol), in a deal worth US$28.9m.

On 10 June 2025, Outlook Therapeutics announced that the Scottish Medicines Consortium has accepted Lytenava™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet AMD.

Earlier this month, Outlook Therapeutics announced that it had launched Lytenava™ in the UK and Germany for wet AMD.  Lytenava™ is the first and only licensed ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the UK.

Lytenava™ (also known as ONS-5010, bevacizumab-vikg/bevacizumab gamma) received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).  Outlook Therapeutics resubmitted a BLA to the US FDA for ONS-5010 in February 2025 after the FDA issued a complete response letter in 2023.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD in March 2025.

On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  The Court’s revocation orders, made before the scheduled end of the trial, bring to a conclusion the patent infringement proceedings commenced by Janssen Biotech (and Janssen-Cilag Pty Ltd) against Samsung Bioepis in August 2024.  The Janssen innovation patents all related to a method of treating ulcerative colitis with ustekinumab.  The Court is yet to issue any reasons for judgment in these proceedings.

This is a second victory for Samsung Bioepis in Australia with the earlier January 2024 Federal Court of Australia patent proceeding concluding with Janssen surrendering the two innovation patents in suit.  These innovation patents again related to a method of treating ulcerative colitis with ustekinumab.

Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was approved in Australia in October 2024.  Other ustekinumab biosimilars approved in Australia are Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Ajemnye® (May 2024) and Wezlana® (January 2024).

Janssen’s Stelara® remains the only PBS-listed ustekinumab product at this stage.  Amgen’s Wezlana® was recommended for listing at the March 2024 PBAC meeting, but the company has advised that it is not proceeding in the PBS listing process at this time.  Celltrion’s SteQeyma® was recommended for PBS-listing at PBAC’s November 2024 meeting and Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting.

On 9 June 2025, Samsung Bioepis announced that it has entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to Janssen’s Stelara® (ustekinumab).

Under the terms of the agreement, Samsung Bioepis is responsible for the development, manufacture and supply of the biosimilars, with NIPRO responsible for their commercialisation in Japan.

This follows Biocon Biologic’s announcement on 21 May 2025, that its commercial partner, Yoshindo, launched Ustekinumab BS Subcutaneous Injection in Japan for the treatment of psoriasis vulgaris and psoriatic arthritis.  In September 2023, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, had received marketing approval for AVT04 (ustekinumab) from the Japanese Ministry of Health, Labor and Welfare.

On 9 June 2025, the US Patent Trial and Appeal Board issued a written decision invalidating all claims of Johns Hopkins University’s US Patent No. 11,591,393 on the basis of anticipation and obviousness.  US Patent No. 11,591,393 is directed to treating patients with microsatellite instable (MSI) or DNA mismatch repair deficient (dMMR) colorectal cancer with pembrolizumab.  The decision was issued in proceedings for inter partes review (IPR) filed by MSD on 20 November 2021 (IPR2024-240).

The following IPRs commenced by MSD in relation to Johns Hopkins University (JHU) patents relating to pembrolizumab remain pending:

• 11,649,287 (IPR2024-00647), 11,629,187 (IPR2024-00649), and 11,634,491 (IPR2024-00650): petitions filed on 13 March 2024, IPRs instituted on 27 September 2024;
• 10,934,356 (IPR2024-00622), 11,325,974 (IPR2024-00623), 11,325,975 (IPR2024-00624) and 11,339,219 (IPR2024-00625): petitions filed on 4 March 2024, IPRs instituted on 23 September 2024;
• 11,591,393 (IPR2024-240): petition filed on 30 November 2023, IPR instituted 13 June 2024; and
• 11,643,462 (IPR2024-00648): petition filed 13 March 2024, IPR instituted 3 October 2024.

In November 2022, MSD filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel.  Based on the complaint, the dispute arose out of a contract between MSD and the University to design and conduct a clinical trial on administration regimes for Keytruda® (pembrolizumab) in cancer patients with certain genetic biomarkers.  JHU filed a counter-claim on 12 April 2023, including alleging infringement of each of the patents subject to the IPR proceedings referred to above.  The US Court proceeding has been stayed pending the outcome of the IPRs.  No trial date has been scheduled.

On 9 June 2025, Celltrion announced that its Qoyvolma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC).  Qoyvolma® is Celltrion’s second European ustekinumab biosimilar, following Steqeyma®, which was approved by the EC in August 2024 and launched in the EU in November 2024.

Qoyvolma® received a positive opinion from the EMA’s CHMP in March 2025.  It has been approved with an additional indication to that of Steqeyma®, with moderately to severely active ulcerative colitis in adults included in its list of indications, together with adult and paediatric plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease.

There are a number of ustekinumab biosimilars now marketed in the EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024.  Approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).

On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab).

Formycon expects that Ranivisio® will be launched in Brazil in Q4 2025 by its commercialisation partner, Biomm, with a phased market rollout of Ranivisio® to follow across Latin America.  Marketing authorisations have previously been granted in Peru, El Salvador, Honduras and the Dominican Republic and further approvals in Central and South America are planned.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics).  It has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (marketed as Ravegza® by MS Pharma).

On 5 June 2025, Alvotech and Dr Reddy’s announced that they have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to MSD’s Keytruda® (pembrolizumab).

Under the agreement, Alvotech and Dr Reddy’s will be jointly responsible for developing and manufacturing the pembrolizumab biosimilar and will share all costs and responsibilities.  Subject to certain undisclosed exceptions, each company will have the right to commercialise the product globally.

There are a number of pembrolizumab biosimilars already in clinical trials, including Formycon’s FYB206 (Ph 1 commenced June 2024 in malignant melanoma), Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced in July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 commenced in May 2024).  In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.

On 4 June 2025, Sandoz Australia published a white paper entitled “Pioneering Access for Patients Through Biosimilar Medicines” which outlines proposals for reducing healthcare costs and expanding patient access to biosimilars in Australia.  The white paper is the outcome of a summit of stakeholders held in Canberra, Australia on 10 February 2025.

Noting that “Australia is behind most of its international counterparts in biosimilar uptake in retail pharmacies”, the white paper sets out four key policy proposals explored at the February summit:

• lowering patient co-payments for biosimilars;
• mandating biosimilars for new, treatment naïve patients;
• reducing administrative burdens for clinicians (e.g. removing Pharmaceutical Benefits Scheme (PBS) authority requirements once biosimilar uptake surpasses 70%); and
• reinvesting savings from increased biosimilar uptake into a chronic disease future fund.

The white paper suggests that such policy reforms could result in greater affordability and access to medicines for patients, increased competition and PBS savings, reduced prescribing complexity for healthcare professionals and more sustainable funding for new medicines and long-term health priorities.

On 4 June 2025, Alvotech announced that it has completed the acquisition of Xbrane’s Swedish R&D operations, as well as XB003, biosimilar to UCB’s Cimzia® (certolizumab pegol), in a deal worth US$28.9m.  The deal was initially announced by Alvotech in March 2025, and was approved by Xbrane’s board on 14 April 2025.

The acquisition comes a week after Alvotech expanded its partnership with Advanz Pharma to cover three additional biosimilar candidates in Europe.  The products covered by the agreement are biosimilars to Novartis’ Ilaris® (canakinumab) and Kesimpta® (ofatumumab), and a third, undisclosed early-stage biosimilar.

On 2 June 2025, Biocon announced that its generic liraglutide has been approved by India’s Central Drugs Standard Control Organisation (CDSCO) in 6 mg/ml solution for injection in pre-filled pen and cartridge.

Biocon’s liraglutide, the generic version of Novo Nordisk’s Victoza®, is indicated for the treatment of insufficiently controlled Type 2 diabetes mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise.  The CDSCO approved Biocon’s liraglutide under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities.

Biocon’s liraglutide was the first generic to Victoza® to be approved in the UK in March 2024, and was subsequently launched in February 2025.  In December 2024, Biocon and its European partner, Zentiva, received approval for liraglutide in the European Union.  The first EU-approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024.  Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.

On 2 June 2025, ChosunBiz reported that Celltrion has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Korea.  Avtozma® was approved by Korea’s Ministry of Food and Drug Safety in December 2024 for the same indications as Actemra®.

Just a few days earlier, the Therapeutic Good’s Administration (TGA) approved Avtozma® as the first tocilizumab biosimilar in Australia.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.  Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 2 June 2025, Outlook Therapeutics announced that it has launched Lytenava™ (bevacizumab gamma) in the UK and Germany, for the treatment of nAMD.  Lytenava™ is the first and only authorised ophthalmic formulation of bevacizumab in the EU and UK.

Lytenava™ (ONS-5010, bevacizumab-vikg/bevacizumab gamma) received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).  Outlook Therapeutics resubmitted a BLA to the US FDA for ONS-5010 in February 2025 after the FDA issued a complete response letter in 2023.

Outlook Therapeutics has entered into a strategic collaboration with Cencora in relation to the commercial launch of Lytenava™ globally.  In Europe, Cencora provides launch support including pharmacovigilance, regulatory affairs, quality management, market access support, importation, third-party logistics, distribution and field solutions.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD in March 2025.

On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively.  Wyost® and Jubbonti® are the first and only interchangeable denosumab biosimilars to be approved (in March 2024), and launched, in the US and have the same indications, dosage forms and routes of administration as Amgen’s denosumab products.

The US launch of Sandoz’s denosumab biosimilars follows a settlement agreement entered into by Sandoz and Amgen in April 2024 resolving US patent infringement litigation commenced by Amgen in May 2023 and permitting US launch of Wyost® and Jubbonti® from 31 May 2025.

Wyost® and Jubbonti® are approved in Europe (May 2024) and Australia (August 2024) and, in December 2024, they were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).

There are currently three other sponsors with denosumab biosimilars approved in the US: Fresenius Kabi’s Conexxence® and Bomyntra® (March 2025), Celltrion’s Stoboclo® and Osenvelt® (March 2025) and Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025).  Amgen settled patent litigation against Celltrion regarding denosumab biosimilars in January 2025, permitting US launch of Celltrion’s denosumab biosimilars from 1 June 2025 (Celltrion’s denosumab biosimilars have not yet been launched in the US at the date of this report).  In March 2025, Amgen entered into a global settlement of its patent infringement litigation with Fresenius Kabi, allowing US launch of Fresenius’ denosumab biosimilars in mid-2025 (the precise date is unknown).  BPCIA litigation commenced by Amgen against Samsung Bioepis and Accord/Intas regarding their denosumab biosimilars remains pending.

On 30 May 2025, Australia’s Therapeutic Good’s Administration (TGA) approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), across 5 products:

• Injection concentrated vial: 80mg/4ml (444940), 200mg/10ml (444939) and 400mg/20ml (444943); and
• Solution for injection pre-filled pen: 162mg/0.9ml (444942), and 162mg/0.9ml (AVTPen Autoinjector) (444941).

Avtozma® has been approved for the same indications as Actemra® and is the first tocilizumab biosimilar to be approved in Australia.

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 30 May 2025, Samsung Bioepis announced that it has received marketing approval in South Korea for its second denosumab biosimilar, Xbryk™, biosimilar to Amgen’s Xgeva® (denosumab).  This follows the South Korean approval of Samsung Bioepis’ Obodence™ (biosimilar to Amgen’s Prolia®) in April 2025.

Samsung Bioepis’ denosumab biosimilars were approved in February 2025 in both the US (marketed as Ospomyv™/Xbryk™) and Europe (marketed as Obodence™/Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings are ongoing.

On 28 May 2025, Russia’s GxP News reported that the Russian Ministry of Health approved Russian biotechnology company Biocad’s Pertuvia™, biosimilar to Roche’s Perjeta® (pertuzumab), making it the country’s first domestic biosimilar pertuzumab approved for HER2-positive breast cancer.

This approval comes a month after Roche stated that it did not expect its Perjeta® to face biosimilar competition from Henlius’ HLX11 (pertuzumab) until late 2027.  HLX11 is currently under consideration by regulators in the EU, US and China.

On 27 and 28 May 2025, Bristol Myers Squibb announced that its subcutaneous formulation of Opdivo® (nivolumab), Opdivo® SC (nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20)), has been approved in Europe and Canada across multiple solid tumour indications in monotherapy, in the maintenance phase following combination with ipilimumab (Yervoy®), and in combination regimens with chemotherapy.

The European approval follows the CHMP recommendation earlier in May 2025.  The EU and Canada join the US and UK in approving the subcutaneous formulation.

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development or in contemplation.

Three months after Cytiva subsidiary media supplier HyClone Laboratories filed a motion to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA litigation between Amgen and Fresenius Kabi (subsequently settled), HyClone has filed a similar motion to quash an Amgen subpoena issued in the context of BPCIA patent infringement litigation commenced by Amgen against Accord and Intas.  The motion was filed by HyClone on 14 May 2025 in the US District Court for the District of Utah.  On 28 May 2025, Amgen filed a motion seeking to have the dispute regarding the subpoena transferred to the District of New Jersey.

HyClone is not a party to the underlying BPCIA litigation, which relates to Accord/Intas’ INTP23, biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).  Amgen commenced the BPCIA proceedings against Accord/Intas in November 2024.  The proceedings were then centralised in February 2025 in the US District Court for the District of New Jersey with similar BPCIA proceedings Amgen brought against Samsung Bioepis (August 2024) and Fresenius Kabi (October 2024).

Amgen’s subpoena to HyClone requests 32 categories of information, including the full formulations of HyClone’s cell culture media supplements, marketed as HyClone™ Cell Boost™ 7a Supplement and HyClone™ Cell Boost™ 7b Supplement.  Amgen alleges that this information is necessary because Accord/Intas infringe certain of its patents (eg. US 7,928,205, US 10,513,723 and US 11,254,963) based on concentrations and ingredients in the cell culture media used by Accord to manufacture its denosumab biosimilar.

HyClone argues that the subpoena should be quashed for a number of reasons, including that the information sought is irrelevant and the request is overly burdensome because it would require the disclosure of trade secrets.

Amgen has settled three of its US denosumab disputes over the last 12 months.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025.  Amgen settled its litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025.  In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025.  Amgen’s BPCIA litigation against Accord/Intas and Samsung Bioepis regarding their denosumab biosimilars remains pending.

On 28 May 2025, Alvotech and Advanz Pharma announced that they have entered a supply and commercialisation agreement to expand their existing partnership to cover three additional biosimilar candidates in Europe.  The products covered by the agreement are biosimilars to Novartis’ Ilaris® (canakinumab) and Kesimpta® (ofatumumab), and a third, undisclosed early-stage biosimilar.

Under the agreement, worth up to US$180 million, Alvotech will be responsible for the development and commercial supply of the biosimilars while Advanz Pharma will have responsibility for their registration and commercialisation in Europe.

Alvotech and Advanz previously entered into partnership agreements in February 2023, May 2023 and June 2024 for commercialisation of biosimilars in Europe and certain other countries, including AVT23 (biosimilar to Novartis’ Xolair® (omalizumab)), AVT05 (biosimilar to Janssen’s Simponi® and Simponi Aria® (golimumab)), AVT16 (biosimilar to Takeda’s Entyvio® (vedolizumab)), AVT06 and AVT29 (biosimilars to Regeneron’s Eylea® (aflibercept) in low (2mg) and high (8mg) doses, respectively), and biosimilars to Sanofi/Regeneron’s Dupixent® (dupilumab), Eli Lily’s Taltz® (ixekizumab) and J&J/Janssen’s Tremfya® (guselkumab).

On 27 May 2025, Formycon and Fresenius Kabi announced the Canadian launch of FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The biosimilar is available in both IV and subcutaneous injection presentations to treat adults with moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

FYB202/Otulfi® was developed by Formycon and was approved in Canada and the UK in January 2025 and in the US and Europe in September 2024.  It is being commercialised in Canada, the US, and most of Europe by Fresenius Kabi under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling US launch of FYB202 “no later than 15 April 2025” (the biosimilar’s US launch was in early March 2025).  This was followed by a settlement in March 2024 regarding the commercialisation of FYB202/Otulfi® in Europe and Canada, with the launch dates in those countries previously undisclosed.

On 27 May 2025, Bio-Thera Solutions and Hikma Pharmaceuticals announced that the US FDA has approved BAT2206, marketed as Starjemza® (ustekinumab-hmny), biosimilar to J&J/Janssen’s Stelara® (ustekinumab).

The approval of Starjemza® follows six ustekinumab biosimilars already launched in the US: Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025).

Bio-Thera and Hikma signed an exclusive commercialisation and licence agreement in relation to BAT2206/Starjemza® in August 2021.  Under the agreement, Hikma has exclusive commercialisation rights in the US while Bio-Thera remains responsible for the development and manufacturing of the product.

Bio-Thera also has commercialisation and licence agreements for BAT2206/Starjemza® with Gedeon Richter for the EU, UK, Switzerland and selected other countries (entered October 2024), Dr Reddy’s for certain Southeast Asian countries including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam (entered March 2025), World Medicine for Turkey (entered January 2025), and Tabuk Pharmaceuticals for Saudi Arabia (entered December 2024).

On 27 May 2025, Sandoz’s Afqlir® and Enzeevu®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept 2mg), were approved by Australia’s Therapeutic Good’s Administration (TGA) across 4 products:

• Afqlir® – 40 mg/mL solution for intravitreal injection pre-filled syringe (445959) and vial with needle (445960); and
• Enzeevu® – 40 mg/mL solution for intravitreal injection pre-filled syringe (445957) and vial with needle (445958).

All products are approved for the same indications as the reference products, including nAMD, visual impairment due to macular oedema secondary to central retinal vein occlusion; visual impairment due to macular oedema secondary to branch retinal vein occlusion; diabetic macular oedema; and visual impairment due to myopic choroidal neovascularisation.

This approval makes Sandoz the second sponsor to have aflibercept biosimilars approved in Australia.  Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).  Sandoz’s aflibercept biosimilars will be the first to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting, indicating that Sandoz may well be the first to launch in Australia.

On 27 May 2025, Samsung Bioepis announced that it has secured expanded interchangeability designation in the US for its Hadlima™ (adalimumab-aaty), biosimilar to AbbVie’s Humira®, in high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe.  This follows interchangeability designation for Hadlima™ in low-concentration prefilled syringe and single-dose vial presentations granted in June 2024.  According to Samsung Bioepis, with this latest designation, Hadlima™ is now fully interchangeable with Humira®.

A few days earlier, on 23 May 2025, Celltrion announced that the US FDA has granted an expanded interchangeable designation for its high concentration adalimumab biosimilar, Yuflyma® (adalimumab-aaty), to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations.  This follows interchangeability designation granted to its high-concentration 20mg and 80mg pre-filled syringe presentations in April 2025.  According to Celltrion, Yuflyma® is now fully interchangeable with Humira® across all of Yuflyma®’s marketed dosage forms and strengths.

The first high-concentration biosimilar to AbbVie’s Humira® to receive an interchangeability designation was Alvotech and Teva’s Simlandi®, which was approved in February 2024.

On 25 May 2025, Biocon Biologics announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  Yesintek® is indicated for treatment of adults and children from 6 years with moderate to severe plaque psoriasis and adults with active psoriatic arthritis or moderately to severely active Crohn’s disease.

The European Commission granted marketing authorisation for Yesintek™ in February 2025.  In the same month, Biocon launched Yesintek® in the US, following its US approval in early December 2024.

In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200/Yesintek® in Europe, the United Kingdom, Canada and Japan (launch date unknown).

There are a number of ustekinumab biosimilars already approved in the UK, including Dong A-ST/Intas’ Imuldosa® (launched April 2025), Formycon/Fresenius’ Otulfi®/FYB202 (approved January 2025), Celltrion’s Steqeyma® (approved September 2024), Samsung Bioepis’ Pyzchiva® (approved May 2024), STADA’s Uzpruvo® (approved March 2024) and Amgen’s Wezenla™ (approved January 2024).

On 29 May 2025, Hengrui Pharma announced that China’s National Medical Products Association (NMPA) granted approval to its antibody drug conjugate trastuzumab rezetecan for use as a treatment in adult patients with unresectable locally advanced or metastatic non-small cell lung cancer mutations who have previously received at least one systemic therapy.

On 23 May 2025, AstraZeneca and Daiichi Sankyo announced that Canada’s Drug Agency has recommended a Time-Limited Reimbursement for Enhertu® (trastuzumab deruxtecan).  According to AstraZeneca, the recommendation recognises and responds to the unmet need for treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.  This decision marks the first Time-Limited Reimbursement to be awarded to a product used in the treatment of gastric cancer in Canada.

On 23 May 2025, Bayer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a label extension for Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) with expanded treatment intervals of up to 6 months for nAMD and diabetic macular oedema.  Bayer expects marketing authorisation from the European Commission within the next few weeks.

This news comes two days after Bayer’s 21 May 2025 announcement that the Center for Drug Evaluation of China’s National Medical Products Administration has approved Eylea™ 8mg (aflibercept 8mg) for nAMD in China.

Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea™ in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Regeneron/Bayer have recently submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following retinal vein occlusion (RVO) in Japan (May 2025), Europe (April 2025) and the US (application accepted by FDA for priority review in April 2025, with a target action date of 19 August 2025).

On 22 May 2025, GSK announced that the US FDA has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.

The FDA accepted GSK’s application for the indication expansion in December 2024.  Corresponding applications have been accepted by the European Medicines Agency (March 2025) and China’s National Medical Products Administration (February 2024).

Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Phase 1 trials (according to the company’s pipeline), and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the marketing rights of the drug across Latin America.

At its May 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three denosumab biosimilars: Sandoz’s Rolcya®, biosimilar to Amgen’s Prolia®, and Fresenius Kabi’s Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® respectively.

Rolcya® is a second Prolia® biosimilar for Sandoz, which was the first sponsor to obtain approval of denosumab biosimilars in Europe in May 2024 with Wyost® and Jubbonti®.  Sandoz has previously reported that it expects to launch Wyost® and Jubbonti® in Europe from November 2025.

Fresenius Kabi entered a global settlement with Amgen in respect of its denosumab biosimilars in March 2025.  The settlement resulted in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen against Fresenius in October 2024.  The global settlement permits European launch of Fresenius’ biosimilars “later in H2 of 2025” and launch in the US in “mid-2025”.

In addition to Sandoz’s Wyost® and Jubbonti®, there have been two other sponsors with denosumab biosimilars approved in Europe to date:  Celltrion’s Stoboclo®/Osenvelt® (February 2025) and Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025).  CHMP positive opinions were adopted in March 2025 for Accord Healtcare’s Jubereq®/Osvyrti® and in April 2025 for Gedeon Richter’s Junod®/Yaxwer® (April 2025), Biocon’s Vevzuo®/Denosumab BBL (brand name currently under approval), mAbxience’s Izamby®/Denbrayce® and Zentiva’s Zadenvi®/Enwylma®.

On 21 May 2025, Biocon Biologics announced that Yoshindo, its commercial partner, has launched Ustekinumab BS Subcutaneous Injection in Japan for treatment of psoriasis vulgaris and psoriatic arthritis.

The launch follows the January 2025 approval of the subcutaneous ustekinumab (Bmab 1200), biosimilar to J&J/Janssen’s Stelara®, by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Biocon signed a patent settlement and licence agreement with J&J/Janssen in 2024, which resolved patent disputes between the parties, and enables Biocon to commercialise its ustekinumab biosimilar (Bmab 1200/Yesintek®) in Europe, the United Kingdom, Canada and Japan.

Biocon launched Yesintek™ in the US in February 2025 following its approval in early December 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.  Yesintek® was approved in Europe in February 2025.

On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic bundling rebates, involving its anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast), to convince pharmacy benefit managers (PBMs) to choose Repatha® (evolocumab) as their exclusive PCKS9 product, instead of Regeneron’s Praluent® (alirocumab).  According to Regeneron, Amgen threatened to withhold rebates unless PBMs preferred its cholesterol-lowering antibody, Repatha®, and excluded Regeneron’s Praluent®.

The jury awarded Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.  It is not yet known whether Amgen will appeal the decision.

On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab).  On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid, based on lack of inventive step.  Amgen has recently had more fortune in Australia, where, on 23 April 2025, the Federal Court determined that five of Amgen’s evolocumab-related patent applications are valid and should proceed to grant.

On 21 May 2025, Sandoz announced the launch of its Pyzchiva® autoinjector as the first commercially available biosimilar ustekinumab pre-filled pen in Europe.  The autoinjector is currently available in Spain and Sandoz will continue to roll it out across Europe.

The Pyzchiva® autoinjector is delivered through the Molly® platform of SHL Medical AG and is available as a 90 mg in 1 mL autoinjector or a 45 mg in 0.5 mL autoinjector.

Pyzchiva®, biosimilar to J&J’s Stelara® (ustekinumab), was developed and registered by Samsung Bioepis.  Under a development and commercialisation agreement with Samsung Bioepis entered in September 2023, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.

Pyzchiva® was first approved in Europe in April 2024 for treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis for patients aged 6 years and older.  Sandoz launched Pzychiva® in Europe in July 2024 (as vial for infusion/PFS).  Although Pyzchiva® was not the first approved ustekinumab biosimilar product in Europe (it followed approval of Alvotech/Stada’s Uzpruvo® in January 2024 and announcement of its launch on 22 July 2024), it was the first ustekinumab biosimilar to be available in all reference medicine strengths.  In addition to the autoinjector, Pyzchiva® is available as a 130mg concentrate in a vial for solution for infusion, and a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe.

On 21 May 2025, Mr Justice Meade of the High Court of Justice for England and Wales delivered his decision in proceedings involving allegations of patent infringement by Alexion against each of Samsung Bioepis and Amgen, finding Alexion’s asserted patent to be not infringed and invalid.

Alexion alleged that Samsung Bioepis’ Epysqli® and Amgen’s Bekemv®, biosimilars to Alexion’s Soliris® (eculizumab), infringed European Patent (UK) No. 3 167 888 B1, granted on 1 May 2024.  The Court held there was no infringement on the basis that the relevant claims of the patent claimed a light chain antibody sequence which had 22 amino acids (a leader sequence) not present in eculizumab.  The Court further held that Alexion’s patent was invalid for obviousness/lack of inventive step.  It is not yet known whether Alexion will appeal the decision.

The UK judgment follows decisions of the UPC (June 2024) and the UPC Court of Appeal (December 2024), refusing to grant preliminary injunctions against Amgen and Samsung Bioepis in relation to the sale of their eculizumab biosimilars in the EU.

In contrast to the decision in the UK and Europe, less than two weeks ago, the Canadian Federal Court published a decision (issued on 28 April 2025 on a confidential basis) granting Alexion an injunction preventing the Canadian launch of Amgen’s Bkemv® until 15 March 2027.  This decision was based on the Court’s finding that claims 1 and 2 of Alexion’s Canadian patent no. 2645810 are valid and infringed by Amgen.

In the US, a class action complaint was filed in April 2025 by EmblemHealth, alleging that Alexion unlawfully delayed the introduction of biosimilar competition to Soliris® by misusing its patents.  That lawsuit followed the launch of Teva/Samsung Bioepis’ Epysqli® in April 2025 and Amgen’s Bkemv® in March 2025.  Both Samsung Bioepis (in August 2024) and Amgen (in May 2020) reached settlements with Alexion in relation to their US eculizumab biosimilars.

On 20 May 2025, Johnson & Johnson (J&J) announced that the US FDA has voted (6-2) in favour of the benefit-risk profile of single-agent Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM).  J&J submitted its application to the US FDA for approval of this indication in November 2024.

On 19 May 2025, Formycon and Fresenius Kabi announced that the US FDA has designated FYB202/Otulfi® (ustekinumab-aauz) as interchangeable with J&J/Janssen’s Stelara® (ustekinumab) in all presentations of the reference product.

FYB202/Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024.  It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.

In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling US launch of FYB202/Otulfi® “no later than 15 April 2025”.  FYB202/Otulfi® was the fourth ustekinumab biosimilar to be launched in the US in early March 2025.

Amgen’s Wezlana® was the first ustekinumab biosimilar to be approved as interchangeable with Stelara® in the US on October 2023, followed by Alvotech/Teva’s Selarsdi® in early May 2025.

On 16 May 2025, Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo® for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.

This follows the March 2025 CHMP recommendation for the indication.  At its March 2025 meeting, the CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).  Subcutaneous Opdivo® has previously been approved in the US (December 2024) and the UK (April 2025) for most but not all previously approved adult, solid tumour indications.

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development or in contemplation.

On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic bundling rebates, involving its anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast), to convince pharmacy benefit managers (PBMs) to choose Repatha® (evolocumab) as their exclusive PCKS9 product, instead of Regeneron’s Praluent® (alirocumab).  According to Regeneron, Amgen threatened to withhold rebates unless PBMs preferred its cholesterol-lowering antibody, Repatha®, and excluded Regeneron’s Praluent®.

The jury awarded Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.  It is not yet known whether Amgen will appeal the decision.

On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab).  On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid, based on lack of inventive step.  Amgen has recently had more fortune in Australia, where, on 23 April 2025, the Federal Court determined that five of Amgen’s evolocumab-related patent applications are valid and should proceed to grant.

On 14 May 2025, Sanofi announced that Singapore’s Health Sciences Authority (HSA) has approved Dupixent® (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils who are on a stable combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.  Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

In Singapore, Dupixent® is the first biologic medicine approved to treat these COPD patients and follows approval of the same indication in Japan in March 2025.

Dupixent® was also approved in the US and China, and the UK, as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype in September 2024.  In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.

Dupixent® was also recently approved by the US FDA for Chronic Spontaneous Urticaria (CSU) in  April 2025.  Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

On 12 May 2025, the Canadian Federal Court published a decision (issued on 28 April 2025 on a confidential basis) granting Alexion an injunction preventing the Canadian launch of Amgen’s Bkemv®, biosimilar to Alexion’s Soliris® (eculizumab), until 15 March 2027.  The decision is based on the Court’s finding that claims 1 and 2 of Alexion’s Canadian patent no. 2645810 (which encompass eculizumab) are valid and infringed by Bkemv®.

Subject to any appeal, the injunction will remain in force until 15 March 2027, the date on which Alexion’s ‘810 patent expires.  The Court also ordered Amgen to deliver up to Alexion or destroy (at Alexion’s election) all eculizumab product (including any intermediates) that would breach the injunction.

The Canadian decision comes a month after a class action complaint was filed in the US by EmblemHealth, alleging that Alexion unlawfully delayed the introduction of biosimilar competition to Soliris® by misusing its patents.  That lawsuit followed the launch of two eculizumab biosimilars in the US: Teva/Samsung Bioepis’ Epysqli® in April 2025 and Amgen’s Bkemv® in March 2025.  Both Samsung Bioepis (in September 2024) and Amgen (in May 2020) reached settlements with Alexion in relation to their US eculizumab biosimilars.

On 9 May 2025, New Zealand’s drug funding body, Pharmac, announced that it will be widening access to treatments for melanoma from 1 June 2025, including funding MSD’s Keytruda® (pembrolizumab) for resectable stage IIIB to stage IV melanoma, subject to eligibility criteria.

Pembrolizumab is currently already funded in New Zealand for eligible patients with unresectable or metastatic melanoma.

There are pembrolizumab biosimilars in clinical trials for the treatment of melanoma, including Sandoz’s GME751 (Phase 1 trial in resected advanced melanoma) and Formycon’s FYB206 (Phase 1 trial commenced in June 2024 comparing the pharmacokinetics, safety and tolerability of FYB206 with Keytruda® in malignant melanoma).

On 9 May 2025, Bayer announced that it has submitted a marketing authorisation application to the Ministry of Health, Labour and Welfare in Japan for Eylea™/aflibercept 8mg for treating patients with macular oedema following retinal vein occlusion (RVO).

This comes a month after Bayer filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg for the same indication in April 2025.

Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea™ in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Regeneron’s sBLA for Eylea HD® for treatment of macular oedema following RVO, and for broadening the dosing schedule to include monthly dosing across approved indications, was accepted by the FDA for Priority Review in April 2025.  The FDA’s target action date is 19 August 2025.

On 8 May 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan) in 100 mg solution for infusion as monotherapy for the treatment of adult patients with unresectable or metastatic HER2- low or HER2- ultralow breast cancer, who have previously received at least one endocrine therapy in metastatic setting.

The same indication was approved by the US FDA in January 2025, following the grant of priority review in October 2024.

Enhertu® has recently been considered for reimbursement by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) at its May 2025 meeting – the outcomes are yet to be published.  In December 2024, New Zealand’s Pharmac announced additional funding for Enhertu® for people with HER2-positive metastatic breast cancer.

On 7 May 2025, Johnson & Johnson announced that the European Commission (EC) has approved Tremfya® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

This follows the recent EU approval of Tremfya® in April 2025 for the treatment of patients with moderately to severely active ulcerative colitis who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

In March 2025, Tremfya® was approved by the US FDA for adult patients with moderately to severely active Crohn’s disease.  Tremfya® is also approved in the US for a number of other indications, including for ulcerative colitis (September 2024) and plaque psoriasis (July 2017).

On 6 May 2025, India’s Central Drugs Standard Control Organization (CDSCO) published draft revised guidelines on biosimilars, which update marketing authorisation requirements for biosimilars in line with recent international guidelines.  Given regulatory agencies of major countries are moving toward waiving non-clinical studies, the revisions focus on strengthening orthogonal analytical tools and in vitro studies to establish similarity between biosimilars and their reference products.

The revisions to the guidelines include the introduction of scientific considerations and key principles for licensing biosimilars; a revised pathway for approval of biosimilars in India; the introduction of “next generation analytical methodologies” to establish analytical similarity; and new guidance on determining the need for in vivo animal studies.

India’s biosimilar guidelines were last updated in 2016.  Stakeholders have until 5 June 2025 to submit comments on the new draft in Word format to biological@cdsco.nic.in.

The publication of India’s revised draft biosimilar guidelines follow reviews being undertaking by US and EU regulatory agencies for the purpose of streamlining biosimilar development: in particular, the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and the FDA’s 2024 guidance on biosimilar interchangeability.

On 5 May 2025, Biocon Biologics announced that it has entered multiple market access agreements in the US for Yesintek®, biosimilar to J&J’s Stelara® (ustekinumab).  This includes the addition of Yeskintek® to the National Preferred Formulary (NPF) from 21 March 2025, Cigna’s commercial formulary from 21 March 2025, various United Healthcare formularies from 21 March 2025 and managed Medicaid from 1 March 2025.  Yesintek® is also due to be added to Medicare from 1 June 2025, CVS Health from 1 July 2025 and Optum Rx from 1 July 2025.

Biocon launched Yesintek™ in the US in February 2025 following its approval in early December 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.

In March 2025 Celltrion announced the addition of its ustekinumab biosimilar, Steqeyma® to the US Costco Member Prescription Program.  According to Samsung Bioepis’ Q1/2025 US Biosimilar Market Report, ustekinumab biosimilar entrants to the US market in 2025 have provided steep WAC discounts of over 80%.

On 5 May 2025, Alvotech and Teva announced that the US FDA has approved Selarsdi® (ustekinumab-aekn) as interchangeable with J&J’s Stelara® (ustekinumab) in all presentations, including for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

According to an Alvotech/Teva announcement in February 2025, the FDA had granted Selarsdi® a provisional determination of interchangeability to commence after the expiry of exclusivity for Amgen’s Wezlana® (the first ustekinumab biosimilar to be approved as interchangeable in the US) on 30 April 2025.  Wezlana® and Selarsdi® are the only ustekinumab biosimilars currently approved by the FDA as interchangeable with Stelara®.

Selarsdi® was the second ustekinumab biosimilar launched in the US, in February 2025, following a settlement between Alvotech/Teva and J&J entered in June 2023, which permitted the US launch of the biosimilar from 21 February 2025.  Four other ustekinumab biosimilars have also been launched in the US to date: Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025).

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates.  The partnership was expanded in July 2023 to include four additional products.

On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar.  J&J filed an appeal on 30 April 2025.  Neither the Court’s ruling on the preliminary injunction, nor the appeal filing, are publicly accessible as at 1 May 2025.

Subject to the outcome of the appeal, Samsung Bioepis is now clear to sell private label brands in the US, in addition to Pyzchiva® which Samsung Bioepis has been selling since February 2025.

J&J/Janssen commenced the US action on 24 February 2025, alleging that Samsung Bioepis had breached a settlement and licence agreement entered in July 2023 (announced in November 2023), permitting Samsung Bioepis to launch Pyzchiva® (SB17) (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025.  The settlement agreement resolved pending US patent litigation between the companies at the time it was signed.

The complaint, filed the same day on which the US launch of Pyzchiva® was announced, claimed that Samsung Bioepis had entered into an unauthorised sublicence with a private label provider, described in J&J’s complaint as a member of a vertically integrated health conglomerate that includes a health insurer, health care provider, pharmacy chain and pharmacy benefits manager (PBM).  According to J&J, the 2023 settlement agreement did not permit Samsung Bioepis to authorise the private label provider to launch in the US an additional, private label version of biosimilar ustekinumab.

Pyzchiva® was approved by the US FDA in July 2024 for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  It is commercialised in the US (and Europe and Canada) by Sandoz pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

On 30 April 2025, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an update to the European Union (EU) label for Phesgo® to allow administration outside of a clinical setting, such as in a person’s home, by a healthcare professional.  Phesgo® is a subcutaneous fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), used to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Earlier this month, in its 2025 first quarter earnings call, Roche described its biosimilar exposure for its Perjeta® (pertuzumab) as “relatively limited” and “not a threat that we’re super worried about right now,” considering the lack of potential competitors in late-stage development or filing.  Roche believes that the most-advanced pertuzumab biosimilar, Henlius’ HLX11, is unlikely to enter the market until at least late 2027.

HLX11 is currently under consideration for regulatory approval in the EU (March 2025), US (February 2025) and China (December 2024).  In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

On 30 April 2025, when announcing its Q1/2025 financial results, Sandoz indicated that it will be “minimising” the Phase 3 trial of its biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with untreated metastatic non-squamous non-small cell lung cancer.  The decision reportedly follows communications between Sandoz and the US FDA and the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars.

According to Sandoz, it will continue its Phase 1 trial as planned.  The Phase 1 trial is investigating the pharmacokinetic similarity and efficacy, safety, and immunogenicity of Sandoz’s pembrolizumab biosimilar, GME751, compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.

This follows a similar announcement by Formycon in February 2025 regarding the premature termination of its “Lotus” Phase 3 trial of FYB206, biosimilar to Keytruda®.  According to Formycon, following “intensive scientific dialogue” with the US FDA, it concluded that the Phase 3 study was no longer necessary for the development and US approval of FYB206.  Instead, Formycon proposes to rely on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.

On 30 April 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a subcutaneous (SC) formulation of BMS’ Opdivo® (nivolumab).  The SC formulation of nivolumab can be given as a 3–5 minute injection instead of the 30 or 60 minute intravenous (IV) infusion.

Amgen currently has a nivolumab biosimilar under development, having enrolled patients in a Phase 3 study evaluating the efficacy, safety, and immunogenicity of Amgen’s ABP 206 compared with Opdivo®.  The study is expected to be completed in 2027.

Sandoz is also developing a biosimilar of nivolumab and is recruiting patients for an integrated Phase I/III trial in the advanced melanoma setting.

On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced that they have entered into a global collaboration agreement to commercialise a biosimilar of BMS’ Yervoy® (ipilimumab).

Under the agreement, Henlius will develop and manufacture the biosimilar, HLX13, while Sandoz has the exclusive commercialisation rights in the US, Europe, Canada, Japan and Australia.  Henlius will receive an upfront payment of USD 31 million, and up to USD 270 million in milestone payments.

Ipilimumab is approved in combination with nivolumab (BMS’ Opdivo®) for metastatic melanoma and other cancers.  The Henlius deal will therefore complement Sandoz’s development of its own biosimilar to nivolumab, in relation to which Sandoz is recruiting patients for an integrated Phase I/III trial in the advanced melanoma setting.

At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Aurobindo Pharma’s subsidiary CuraTeQ’s Dazublys® (150 mg powder for concentrate for solution for infusion), biosimilar to Roche’s Herceptin® (trastuzumab).  The biosimilar is indicated for HER2-positive metastatic and early breast cancers.  According to Aurobindo, European Commission approval is expected in July 2025.

The first trastuzumab biosimilar was approved in the EU in November 2017 and in the US in December 2017.

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars.

Gedeon Richter’s Junod® and Yaxwer®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, received positive opinions for all indications of the reference medicines.  The EMA had accepted Richter’s MAA for review in July 2024.  Gedeon Richter’s denosumab biosimilars are the first monoclonal antibodies in the company’s biosimilar portfolio.

Biocon Biologics’ Vevzuo® (reference: Xgeva®) and Denosumab BBL (brand name currently under approval) (reference: Prolia®) were also recommended by CHMP.  The European sponsor for the products is Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.

Positive recommendations were also given to mAbxience’s Izamby® and Zentiva’s Zadenvi®, both biosimilars to Prolia®.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

On 24 April 2025, Samsung Bioepis published its ninth quarterly US Biosimilar Market Report, which has been released every quarter since April 2023.  The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q2/2025 edition reports that, as of March 2025, the FDA has approved a total of 73 biosimilars across 19 unique biological molecules, with 48 of those having launched in the US market.  Of note, in Q1/2025, six new ustekinumab biosimilars were launched in the US: Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025).  According to Samsung Bioepis’ Report, ustekinumab biosimilar entrants provided steep WAC discounts of over 80%.  In comparison, Amgen’s Pavblu®, the only aflibercept biosimilar available in the US at the time of the Report, launched with WAC 12% lower than that of Regeneron’s Eylea®.

The Report also outlines reviews being undertaking by US and EU regulatory agencies for the purpose of streamlining biosimilar development: in particular, the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and the FDA’s guidance on biosimilar interchangeability.

On 24 April 2024, Halozyme Therapeutics announced that it has sued MSD for patent infringement in the US District Court for the District of New Jersey.  Halozyme is alleging that MSD’s subcutaneous formulation of Keytruda® (pembrolizumab) infringes 15 patents owned by Halozyme in relation to MDASE subcutaneous delivery technology.

Halozyme’s complaint states that the patents “arise out of Halozyme’s extensive research” regarding “modifications to a human hyaluronidase, known as PH20” which, amongst other things “allows for rapid subcutaneous administration of therapeutic drugs”.  Halozyme alleges that MSD’s SC Keytruda® includes berahyaluronidase alfa, a modified PH20 which “includes the amino acid modifications … covered by the asserted patents”.

Halozyme is seeking damages and an injunction preventing the manufacture, sale and import of SC Keytruda® in the US.  MSD is yet to file its defence.

The lawsuit follows reports in March 2025 that Halozyme had offered MSD an opportunity to licence its MDASE patents.  At the time, a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD has filed petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of ten of Halozyme’s US patents, eight of which are asserted in the litigation.  The petitions, which are currently pending, were filed between November 2024 and April 2025 in relation to: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758, US 12060590, US 12049652, US 12104185 and US 12037618.

In November 2024, MSD revealed positive topline results from its Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy.  The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).  At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck announced an expected 2025 launch for SC Keytruda®.

On 24 April 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) March 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).

Sandoz’s natalizumab biosimilar, Tyruko® (300 mg in 15 mL vial for intravenous infusion) has been recommended for PBS-listing under the same circumstances as Biogen’s Tysabri®.  Tyruko®, which was developed by Polpharma Biologics, is the first and only biosimilar natalizumab to have been approved in Australia (4 April 2025).

Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was recommended for PBS-listing (as 75 mg/0.5 mL and 150 mg/1 mL PFS) for the treatment of uncontrolled severe asthma, uncontrolled severe allergic asthma and severe chronic spontaneous urticaria.  The PBAC considered that “the application of biosimilar uptake drivers to Omlyclo® would be clinically appropriate and would not impact cost effectiveness”.  Such biosimilar uptake drivers include an Authority Required requirement for the inclusion of an administrative note across all Omlyclo® listings encouraging use of the biosimilar brand for treatment naïve patients.  Omlyclo® is the first, and currently only, omalizumab biosimilar approved in Australia (November 2024).

Samsung Bioepis’ Epyztek® (ustekinumab) is recommended for PBS-listing for the same indications as its reference biologic, J&J’s Stelara®, in three forms: 45 mg/0.5 mL in a 0.5 mg PFS for injection, 90 mg/1 mL PFS for injection and solution for IV infusion 130 mg in 26 mL.  As for Omlyclo®, PBAC considered that the application of biosimilar uptake drives to Epyztek® would be appropriate.  Epyztek® was the fourth ustekinumab biosimilar to be approved in Australia in October 2024, following Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024).  Australia’s PBAC recommended Wezlana® for PBS listing at its March 2024 meeting.

The UK’s National Institute for Health and Care Excellence has recommended NHS funding for Bristol Myers Squibb’s immunotherapy combination Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for metastatic colorectal cancer patients who have high microsatellite instability (MSI-high) or mismatch repair deficiency (dMMR).

This follows recent approval of this combination for this indication in the US and Europe, while applications remain pending in Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024).

On 18 April 2025, Sanofi and Regeneron announced that Dupixent (dupilumab) received FDA approval as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU).  The FDA had accepted Sanofi/Regeneron’s resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for the treatment of CSU in November 2024, with a target action date of 18 April 2025.

Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

On 18 April 2025, Regeneron announced that it received a complete response letter (CRL) from the US FDA regarding the supplemental Biologics Licence Application (sBLA) for Eylea HD® (aflibercept, 8mg injection) with extended dosing intervals (up to every 24 weeks) across all approved indications.

Eylea HD® is currently approved in the US with dosing intervals of every 8-16 weeks for nAMD and diabetic macular oedema (DME), and every 8-12 weeks for diabetic retinopathy (DR), following 3 initial monthly doses.  According to Regeneron, the CRL “did not identify any issues with the safety or efficacy of Eylea HD® in its approved indications and dosing regimens”.  Regeneron is “evaluating the FDA’s decision and will determine a path forward in due course.”

This news comes only a day after Regeneron’s sBLA for Eylea HD® for treatment of macular oedema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include monthly dosing across approved indications, was accepted by the FDA for Priority Review.  The FDA’s target action date is 19 August 2025.

Eylea HD® (known as Eylea™ 8mg in Europe) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Bayer filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg for the treatment of macular oedema following RVO earlier in April 2025.

On 16 April 2025, EmblemHealth, a US nonprofit health insurer, filed a class action complaint in the US District Court for the District of Massachusetts alleging that AstraZeneca subsidiary, Alexion Pharmaceuticals, has unlawfully delayed the introduction of biosimilar competition to Soliris® (eculizumab) by misusing its patents.

According to Emblem’s complaint, Alexion wrongly obtained new patents to block biosimilar versions of Soliris® for four years after its patents on the drug should have expired.  Emblem seeks compensation on behalf of US purchasers of eculizumab for “overpayments” they allegedly made (estimated to exceed USD 2 billion) during the four-year delay in biosimilar availability as well as an order ending Alexion’s “monopoly” on Soliris®.

The lawsuit follows the launch of two eculizumab biosimilars in the US: Teva/Samsung Bioepis’ Epysqli® on 7 April 2025 and Amgen’s Bkemv® in March 2025.  Both Samsung Bioepis (in September 2024) and Amgen (in May 2020) reached settlements with Alexion in relation to their eculizumab biosimilars.

On 16 April 2025, Shanghai-based CDMO, Chime Biologics, announced that it has entered a strategic cooperation agreement with Polpharma Biologics “to advance the end-to-end development and manufacture” of an undisclosed biosimilar product for the global market.  Under the agreement, Chime will provide Polpharma with biosimilar development support, including drug investigation and supply capabilities.

Polpharma currently manufactures biosimilars of natalizumab and ranibizumab.  Its Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), is approved in Europe (September 2023) the US (August 2023) and Australia (April 2025), and is marketed and distributed by Sandoz under a global commercialisation agreement.

On 15 April 2025, Petrovax Pharm announced that it is launching its denosumab biosimilar (Forsedeno®) in the Russian market after the Russian Ministry of Health granted marketing authorisation.  This marks Russia’s first approved denosumab biosimilar to Amgen’s Prolia/Xgeva.

Petrovax Pharm acquired the rights to the denosumab biosimilar in Russia under an agreement with AryoGen Pharmed (part of CinnaGen Group).

In August 2024 Bio-Thera and Pharmapark entered a licence and supply agreement for a secukinumab biosimilar in Russia.

On 15 April 2025, Biocon announced that it has entered a settlement and licence agreement with Regeneron, agreeing to dismiss pending US BPCIA litigation regarding its Eylea® (aflibercept) biosimilar, Yesafili™.  The agreement paves the way for a US launch of Yesafili™ (approved May 2024) in the second half of 2026, or earlier under certain undisclosed circumstances.

The US District Court for the Northern District of Virginia had granted a permanent injunction against Biocon on 11 June 2024, preventing the launch of Yesafili™ based on findings of infringement of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  The appeal of the injunction order, and the substantive proceeding against Biocon involving additional Regeneron patents, have now been dismissed and the permanent injunction has been lifted.

The litigation against Biocon was part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Amgen (Pavblu™ approved August 2024), Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024).

Amgen’s Pavblu® was launched in the US in October 2024 following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction earlier in October 2024.  However, preliminary injunctions were granted, and remain in place, preventing biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).  Samsung Bioepis, Formycon and Celltrion are challenging the validity of Regeneron’s ‘865 patent before the USPTO, each having filed a petition for IPR (inter partes review) in November 2024, December 2024 and January 2025, respectively.

On 14 April 2025, Sandoz announced that it has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia in relation to etanercept.  Sandoz’s complaint, filed on 11 April, alleges that Amgen has “unlawfully extended and entrenched its monopoly” for Enbrel® (etanercept) by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.

The complaint relates to Amgen’s purchase of exclusive US rights to certain etanercept-related patents owned by Roche (referred to as the Brockhaus Patents).  According to Sandoz, the purchase of those rights was anti-competitive, as was Amgen’s use of certain Brockhaus Patents (US 8,063,182 and US 8,163,522, having a latest expiry date in 2029) to “eliminate competition in the US etanercept market by blocking biosimilar entrants, including Sandoz”.

Amgen commenced BPCIA litigation against Sandoz in February 2016, including for infringement of the ‘182 and ‘522 patents.  Erelzi® received FDA approval in August 2016.  The ‘182 and ‘522 patents were held to be valid and infringed and Sandoz was prevented from launching Erelzi® in the US by way of an injunction that remains in place today.  Sandoz argues that “were it not for Amgen’s unlawful acquisition” of the Brockhaus Patents, Sandoz “would have launched its etanercept biosimilar in the US at least as early as 2019” (when certain Amgen patents expired).

Sandoz is seeking damages and an injunction to prevent Amgen from using the Brockhaus Patents to block biosimilar competition and to allow Sandoz to launch Erelzi® in the US “as soon as possible”.

Erelzi® was approved and launched in Europe in June 2017.

On 14 April, Celltrion announced that it has secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free adalimumab biosimilar, Yuflyma® (adalimumab-aaty).

Celltrion’s high concentration formulation was first approved by the FDA in May 2023, and the company applied for interchangeable status in January 2024.

The first high concentration biosimilar to AbbVie’s Humira® to receive an interchangeability designation was Alvotech and Teva’s Simlandi®, which was approved in February 2024.

There are a number of high concentration adalimumab biosimilars approved in the US, including: Samsung Bioepis’ Hadlima™, Amgen’s Amjevita™, Sandoz’s Hyrimoz®, and Boehringer Ingelheim’s Cyltezo®.

On 10 April 2025, Aurobindo subsidiary, CuraTeQ Biologics, reported its successful Phase I results for BP16, biosimilar to Amgen’s Prolia® (denosumab).

The Phase I study, which included 204 subjects from Australia and New Zealand, showed that BP16 demonstrated comparable safety, pharmacodynamics and immunogenicity profiles to both the European and US versions of Prolia®; successfully meeting all the predefined endpoints.

CuraTeq anticipates completion of its Phase 3 study in women with postmenopausal osteoporosis by May/June 2025.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).  The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

There are four sponsors with denosumab biosimilars approved in the US: Fresenius Kabi’s Conexxence® and Bomyntra® (March 2025), Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).  A number of denosumab biosimilar BLAs are currently under review by the FDA, including for: Alvotech/Dr Reddy’s (March 2025), Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), and Teva (October 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

On 8 April 2025, The Bio reported that Dong-A ST has launched Imuldosa®, biosimilar to J&J’s Stelara® (ustekinumab) in the UK and Ireland, following its launch in Germany in January 2025.

Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma and Dong A-ST acquired the development and commercialisation rights in 2020.  In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals under which Intas received exclusive commercialisation rights to the ustekinumab biosimilar worldwide, excluding Japan, Korea and certain other Asian countries.

Imuldosa® received European approval in December 2024 and FDA approval in October 2024.  In October 2023, Accord BioPharma reached a settlement with Janssen that allows Accord to launch Imuldosa® in the US no later than 15 May 2025.  According to The Bio, Imuldosa is on track for a May 2025 US launch.

Samsung Bioepis has successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.

The Hague Court of Appeal confirmed that the SPC Regulation’s manufacture-for-export exemption did not require trade licences at the time of notification nor that the export countries be duty-free.  The Hague Court of Appeal therefore held that stockpiling for export was permissible under the exemption, facilitating a “Day-1 entry” – for generic and biosimilar medicines after the SPC expires – into the market of the intended export country.

Pyzchiva® was developed by Samsung Bioepis, and was approved in Europe in April 2024.  It is commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.  Sandoz launched Pzychiva® in Europe in July 2024, for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis.  Although Pyzchiva® was not the first approved ustekinumab biosimilar product in Europe (it followed approval of Alvotech/Stada’s Uzpruvo® in January 2024 and announcement of its launch on 22 July 2024), it was the first ustekinumab biosimilar to be available in all reference medicine strengths.

On 8 and 11 April 2025, respectively, BMS announced that the FDA has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment in two new indications:

• for adult and paediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC); and
• for unresectable or metastatic hepatocellular carcinoma.

The FDA granted the BLA for colorectal cancer Breakthrough Therapy Designation and Priority Review status in February this year.  Applications for the same combination therapy and indication are under evaluation in Australia and Japan.

The hepatocellular carcinoma indication has been recently approved in Europe (March 2025) and remains under consideration in Australia (October 2024).

On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of BMS’ US patents relating to methods of treatment using nivolumab and ipilimumab for cancer generally.  Amgen currently has a nivolumab biosimilar under development, having enrolled patients in a Phase 3 study evaluating the efficacy, safety, and immunogenicity of Amgen’s ABP 206 compared with Opdivo®.  The study is expected to be completed in 2027.

On 8 April 2025, Bayer announced that it has filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) for the treatment of macular oedema following retinal vein occlusion (RVO).

Eylea™ 8mg was approved in Europe for nAMD and DME in January 2024, with extended treatment intervals of up to 5 months.  On 10 February 2025, Bayer announced that it had submitted a marketing authorisation application to the EMA for expanded treatment intervals of up to 6 months with Eylea™ 8 mg for both nAMD and DME.

Eylea™ 8mg (known as Eylea® HD in the US) is also approved for nAMD and DME in Japan (January 2024), the UK (January 2024), Korea (April 2024) and Australia (June 2024).  Eylea HD® was approved in the US in August 2023 for nAMD, DME and diabetic retinopathy.

An OcuClick pre-filled syringe presentation of aflibercept 8mg for nMAD and DME is approved in Canada (February 2025), Australia (October 2024) and Europe (September 2024).

Eylea™ 8mg was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

There are currently seven aflibercept 2mg biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025).  Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept 2mg biosimilars.

On 7 April 2025, Teva and Samsung Bioepis announced the US launch of Epysqli® (eculizumab-aagh),  biosimilar to Alexion’s Soliris®.  According to the joint announcement, Epysqli® will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of Soliris®.

This makes Epysqli® the second available eculizumab biosimilar in the US, following the launch of Amgen’s Bkemv® (eculizumab-aeeb) in March 2025.  The timing of the US launch of Bkemv® was governed by a settlement reached by Amgen and Alexion in May 2020, permitting launch from 1 March 2025.

Epysqli® was launched in Germany, Italy and Spain in October 2023 and in Korea in April 2024.  The UPC (June/July 2024) and the UPC Court of Appeal (December 2024) refused to grant preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of their eculizumab biosimilars in the EU.

On 7 April 2025, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma (NDMM) regardless of transplant eligibility.  The indication expansion was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in February this year.

The EC approved the same indication in October 2024, however, only for patients who are eligible for an autologous stem cell transplant (ASCT).  The new approval removes that limitation.

There are a number of daratumumab biosimilars currently under development.  In February 2025, Shanghai Henlius announced that it has entered into a licence agreement with Dr. Reddy’s for HLX15, biosimilar to Darzalex® and Darzalex Faspro® (daratumumab and hyaluronidase-fihi).  In December 2024, Celltrion announced that the US FDA approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of its daratumumab biosimilar, CT-P44, which followed its European IND submission and entry into the global phase 3 trial procedure in November 2024.

On 6 April 2025, ChosunBiz reported that Samsung Bioepis has received approval in South Korea for Obodence™, biosimilar to Amgen’s Prolia® (denosumab).

Obodence™ is Samsung Bioepis’ 10th biosimilar to be approved in South Korea, including following Epyztek® (ustekinumab) in April 2024, Afilivu® (aflibercept) in February 2024, and Episcli® (eculizumab) in January 2024.

Samsung Bioepis’ denosumab biosimilars were approved in February 2025 in both the US (marketed as Ospomyv™/Xbryk™) and Europe (marketed as Obodence™/Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings are ongoing.

On 4 April 2025, the European Commission granted marketing authorisation to Amgen’s Pavblu® (aflibercept 2mg), biosimilar to Bayer/Regeneron’s Eylea® for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DME) or myopic choroidal neovascularisation (CNV).

Pavblu®, together with a second Amgen aflibercept biosimilar Skojoy® (for which the marketing application was withdrawn on 4 March 2025), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in January 2025.

Pavblu® is the seventh aflibercept biosimilar approved in Europe following: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s Baiama® and Ahzantive® (January 2025).

Amgen’s Pavblu® was the first aflibercept biosimilar to be launched in the US in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen’s launch of the product.

The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017.  There are four other bevacizumab biosimilars FDA approved: Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Celltrion’s Vegzelma™ (September 2022), and Bio-Thera/Sandoz’s Avzivi® (December 2023).

On 4 April 2025, Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), was approved by Australia’s Therapeutic Goods Administration (TGA).  This is the first biosimilar natalizumab approved in Australia.

Tyruko®’s Australian approval is for a 300mg/15mL concentrate for infusion vial.  It is indicated as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (MS) to delay the progression of physical disability and to reduce the frequency of relapse.

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) considered Tyruko® for reimbursement at its March 2025 meeting.  The outcomes of that meeting have not yet been published.

Tyruko® was developed by Polpharma Biologics and, under a global commercialisation agreement with Sandoz reached in 2019, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

Tyruko® is approved in Europe (September 2023) and the US (August 2023).

On 4 April 2025, Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration (TGA).  Celltrion is the second sponsor to achieve approval of its denosumab biosimilars in Australia, following approval of Sandoz’s Jubbonti® and Wyost® in August 2024.

In December 2024, Sandoz’s denosumab biosimilars were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).  In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia.

In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

On 3 April 2025, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved by New Zealand’s Medsafe for the same indications as its reference product.

Omlyclo® is the first omalizumab biosimilar approved in New Zealand.  It was also the first omalizumab biosimilar to be approved in the US (March 2025), Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).

Alvotech/Kashiv Biosciences, Aurobindo, Teva and Glenmark are reported to have omalizumab biosimilars under development.

In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK omalizumab formulation patent (EP 3805248), finding it was valid and infringed by Celltrion.

On 2 April 2025, Johnson & Johnson announced that the European Commission has approved Stelara® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.

This follows the adoption of a positive opinion by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for this indication of Stelara® in February 2025.

There are a number of ustekinumab biosimilars marketed in the EU, with three launched during 2024: STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024.  Previously approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).

Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu®, are to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting.

The agenda for the PBAC meeting, published on 2 April 2025, lists the two biosimilars to Regeneron/Bayer’s Eylea® for consideration in relation to macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DMO), and subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD).

Sandoz’s aflibercept biosimilars are not yet ARTG listed, unlike Celltrion’s aflibercept biosimilar, Eydenzelt®, which was the first biosimilar aflibercept approved on 31 March 2025.  However, Sandoz’s aflibercept biosimilars will be the first to be considered by PBAC for reimbursement, indicating that Sandoz will likely be the first to launch in Australia.

On 1 April 2025, Eisai reported that the final process for the European Commission (EC) regulatory review of Eisai’s Marketing Authorisation Application (MAA) for Leqembi® (lecanemab) as a treatment for early Alzheimer’s disease (AD) is underway.

In February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed its positive opinion for Leqembi® for early Alzheimer’s disease.  The EC has deliberated on the MAA in its Standing Committee and has now referred the decision to the Appeal Committee in accordance with the EC review process.

Leqembi® has been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  Australia’s Therapeutic Goods Administration (TGA) declined to approve Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease.

On 1 April 2025, the European Medicines Agency (EMA) published a draft reflection paper questioning whether biosimilars may be approved in future without submission of Comparative Efficacy Studies (CES).  The EMA considers that “[w]aiving certain clinical data requirements would simplify the development and evaluation process” of biosimilars “while maintaining the highest standards of safety and efficacy”.

According to the EMA, advances in analytical characterisation, and its extensive regulatory experience in approving significant changes in manufacturing processes of biological medicines by confirmation of structural and functional comparability, “supports the notion that under specific prerequisites, analytical comparability exercises and pharmacokinetic (PK) data could be sufficient for demonstrating biosimiliarity”.  The EMA also refers to its experience indicating that the results from CES in the past “generally did not add relevant additional information to the biosimilarity exercise”.

The reflection paper concludes that CES may no longer be required for approval of biosimilars “if similar clinical efficacy and safety pharmacology can be inferred from a sufficiently stringent evaluation of analytical comparability, in vitro pharmacology, and a comparative clinical PK trial”.

The EMA is inviting stakeholders to send their comments on the reflection paper via an online EU Survey until 30 September 2025.

On 1 April 2025, Organon announced that it has acquired from Biogen the US regulatory and commercial rights to Tofidence™, biosimilar to Roche’s Actemra® (tocilizumab).  Product developer Bio-Thera Solutions will continue to manufacture the product.

Tofidence™ was the first US approved tocilizumab biosimilar (IV formulation, September 2023), followed by Fresenius Kabi’s Tyenne® (SC formulation, March 2024) and Celltrion’s Avtozma® (IV and SC formulations, February 2025).

Korea Biomedical Review reported on 31 March 2025 that Celltrion has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) regarding its autoinjector formulation of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  The injector formulation will be supplied in 75mg and 150mg doses.

Celltrion’s omalizumab biosimilar was approved (in pre-filled syringe) in the US in March 2025, Canada in December 2024, Australia in November 2024, the UK in July 2024, Korea in June 2024 and Europe in May 2024.

On 31 March 2025, Celltrion’s Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by Australia’s Therapeutic Good’s Administration (TGA) as follows:

• 40 mg/mL solution for intravitreal injection pre-filled syringe (431931); and
• 40 mg/mL solution for intravitreal injection vial with needle (431932).

Eydenzelt® is indicated for the treatment of visual impairment due to myopic choroidal neovascularisation (myopic CNV).

Eydenzelt® is the first aflibercept biosimilar approved in Australia.  It has recently been approved in Europe (February 2025) for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).  Celltrion filed a US NDA in June 2023 for Eydenzelt® and received Korean approval in May 2024.

On 28 March 2025, the US FDA approved AstraZeneca’s Imfinzi® (durvalumab) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).

AstraZeneca’s sBLA for Imfinzi® for the MIBC indication was granted priority review by the FDA in December 2024.  In February 2025, Australia’s TGA accepted for review an indication expansion of Imfinzi® for MIBC.

On 28 March 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency (EMA) has validated their marketing authorisation application (MAA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).

Henlius/Organon have previously had applications for HLX11 accepted by the US FDA (February 2025) and China’s Center for Drug Evaluation of the National Medical Products Administration (December 2024).

In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

On 27 March 2025, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for “frequently relapsing or steroid-dependent nephrotic syndrome” in childhood (IV injection, 100mg and 500mg) that has not yet become intractable.

Rituxan® was approved in Japan in November 2024 for chronic idiopathic thrombocytopenic purpura (ITP) in children. Prior to this, Rituxan® had only been approved in Japan for chronic ITP in adults.

Rituximab was one of the first mAbs to become “biosimilar”.  Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s Riabni^TM (approved by the FDA in December 2020).

At its March meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions for seven indication expansions, including to:

• BMS’ Opdivo® (nivolumab) in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo® as monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression at or higher than 1%.
• Janssen’s Tremfya® (guselkumab) for treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment; and
• Beigene’s Tevimbra® (tislelizumab) in combination with etoposide and platinum chemotherapy, for first-line treatment of adults with extensive-stage SCLC.

The CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).  Subcutaneous Opdivo® has previously been approved in the US for most but not all previously approved adult, solid tumour indications.

On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s RoActemra® (tocilizumab).  This follows Gedeon’s announcement of positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19 in January 2025, both of which met their primary endpoints.

RGB-19 was co-developed by Mochida and Gedeon Richter.  Mochida will file marketing authorisation applications for RGB-19 in Japan, while Richter will do so in major global markets outside Japan.

In February 2025, Celltrion’s Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

On 27 March 2025, MSD announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab plus berahyaluronidase alfa), with indications across all previously approved solid tumour indications for Keytruda®.  The FDA has set a PDUFA, or target action, date of 23 September 2025.

Reuters has reported that MSD intends to launch SC pembrolizumab on 1 October 2025.  This aligns with MSD’s previously expressed expectations of a 2025 launch for the subcutaneous product.

According to MSD, the European Medicines Agency (EMA) has also validated an extension application to introduce a new pharmaceutical form and new route of administration for Keytruda®.

At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars.

Accord Healthcare’s Jubereq® and Osvyrti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab) respectively, have received recommendations for the same indications as the reference products.

In addition, the CHMP has recommended Celltrion’s Qoyvolma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).  The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

There are a number of ustekinumab biosimilars being marketed in the EU, with three launched during 2024, STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024.  Previously approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).

On 27 March 2025, Celltrion announced that its Steqeyma®, biosimilar to J&J’s Stelara® (ustekinumab), has been added to the US Costco Member Prescription Program.  Steqeyma® will be available from US Costco Specialty Pharmacies from 1 April 2025 for self-funded employer plans and Costco members who are uninsured and want to pay cash for their Steqeyma® prescription or who have been denied coverage by their insurers.  According to Celltrion, the wholesale acquisition cost (WAC) for Steqeyma® will be discounted by 85% compared with the current US WAC list price of Stelara®.

Steqeyma® was launched in the US in March 2025 for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, paediatric plaque psoriasis and paediatric psoriatic arthritis.

In August 2024, Celltrion also announced the addition of adalimumab-aaty, biosimilar to AbbVie’s Humira®, to the Costco Member Prescription Program.

On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

In February 2023, Alvotech and Advanz Pharma entered into an exclusive agreement in relation to the commercialisation of AVT23, under which Alvotech was responsible for development and manufacture, while Advanz Pharma handles registration and commercialisation.  In October 2023, Alvotech entered into an exclusive licensing agreement with Kashiv in relation to AVT23.  Under that agreement, Alvotech has an exclusive licence to commercialise AVT23 in the EU, the UK, Australia, Canada, and New Zealand, while Kashiv is responsible for the development and manufacturing of the biosimilar.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was the first to be approved in the UK in July 2024.  In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK patent for an omalizumab formulation (EP (UK) 3 805 248), finding it was valid and infringed by Celltrion.

On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s Stelara® (ustekinumab) and Simponi® (golimumab), respectively.

Under the agreement, Bio-Thera will be responsible for developing, manufacturing and supplying BAT2206 and BAT2506 and Dr Reddy’s will commercialise the products in certain Southeast Asian countries, including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam.  Dr Reddy’s will also receive the exclusive commercial rights to BAT2206 in Colombia.  The SE Asia deal follows agreements that Bio-Thera entered with Intas/Accord in February 2025 and STADA in May 2024 for the commercialisation of golimumab (BAT2506) in the US and Europe, respectively.

In October 2024, Bio-Thera and Gedeon Richter entered into an exclusive commercialisation and licence agreement for BAT2206 (ustekinumab), under which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries.  Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA, and its BLA was accepted by the FDA, in July 2024.  A marketing authorisation application is also currently under review by China’s National Medicinal Product Administration.

On 26 March 2025, Fresenius Kabi announced that the US FDA approved its Biologics Licence Application (BLA) for Conexxence® and Bomyntra® (denosumab-bhnt), biosimilars to Amgen’s Prolia® and Xgeva® respectively, for all reference indications.  Fresenius is the fourth sponsor to have denosumab biosimilars approved in the US.

Under the terms of a settlement between Fresenius Kabi and Amgen, resulting in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen in October 2024, Fresenius Kabi may launch its denosumab biosimilars in the US in “mid-2025”.

Fresenius Kabi has also confirmed that the global settlement permits European launch of its denosumab biosimilars “later in H2 of 2025”, subject to regulatory approvals.

There are three sponsors with denosumab biosimilars already approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).  A number of denosumab biosimilar BLAs are currently under review by the FDA, including for: Alvotech/Dr Reddy’s (March 2025), Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), and Teva (October 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

On 28 March 2025, Sanofi and Regeneron announced that Japan’s Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorisation for Dupixent® (dupliumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.

Dupixent® was approved in the US and China, and the UK, as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype in September 2024.

In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.

On 24 March 2025, GSK announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala® (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

Corresponding applications for the expanded indication have been made to China’s National Medical Products Administration (NMPA) (February 2024) and the US FDA (December 2024).

Bio-Thera is currently developing a mepolizumab biosimilar, BAT2606, which has completed Ph 1 trials according to the company’s pipeline, and is the subject of an exclusive commercialisation deal struck in March 2024 with Costa Rican healthcare product distributor SteinCares for the exclusive marketing rights of the drug across Latin America.

On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease.  According to J&J, Tremfya® is the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options.

Tremfya® is approved in the US for a number of indications, including for the treatment of adults with moderately to severely active ulcerative colitis (September 2024) and adults with plaque psoriasis (PsO) (July 2017).

In December 2024, J&J announced its submission to the FDA of two supplemental Biologics Licence Applications (sBLAs) for approval of Tremfya® for the treatment of children 6 years of age and older with moderate-to-severe PsO and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).

On 20 March 2025, Alvotech announced its acquisition of Xbrane’s Swedish R&D operations, as well as biosimilar candidate XB003 referencing UCB’s Cimzia® (certolizumab pegol).  Xbrane will retain some pre-clinical development programs and will continue to operate as a listed company.

According to Alvotech, the deal is worth approximately USD$27M and is expected to close in April 2025, subject to approvals from the relevant authorities and Xbrane’s shareholders.

In August 2024, Xbrane commenced its out-licensing process for XB003 and in October 2024, announced that it received the first non-binding proposals on XB003.  In that announcement, Xbrane said that it had successfully scaled up the production process to clinical scale, analytical similarity to the reference product had been demonstrated, and scientific advice from EMA and FDA on the clinical development plan was expected in Q1 2025.

On 19 March 2025, the US FDA approved MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-postiive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (CPS≥1).

The Keytruda® combination first received accelerated approval for the HER2 positive Gastric/GEJ cancer indication in May 2021 based on an interim analysis of the KEYNOTE-811 trial, with the indication subsequently being revised in November 2023 to add a restriction to patients whose tumours express PD-L1 (Combined Positive Scope [CPS] ≥ 1) as determined by an FDA-approved test.

Keytruda® (with trastuzumab and chemotherapy) was approved in Europe for the same indication in August 2023.

On 19 March 2025, Korea Biomedical Review (KBR) reported that Daewoong Pharmaceutical has launched Celltrion’s Stoboclo® (CT-P41), biosimilar to Amgen’s Prolia® (denosumab) at a 28% discount.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.

KBR also reported on 19 March 2025, that Samsung Bioepis and Hanmi Pharmaceutical have entered into a joint sales agreement for Samsung Bioepis’ SB16, biosimilar to Amgen’s Prolia® (denosumab).  Under the agreement, Samsung Bioepis will be responsible for the development and supply of the biosimilar, with both companies managing marketing and sales.

While Samsung Bioepis’ denosumab biosimilars have not yet been approved in Korea, they were approved in February 2025 in the US (Ospomyv™/Xbryk™) and Europe (Obodence™/ Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings  are ongoing.

In a joint press release on 18 March 2025, Alvotech and Dr Reddy’s announced that the US FDA has accepted their Biologic Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

According to the companies, AVT03 will be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution, as well as a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.

In May 2024, Dr Reddy’s and Alvotech entered into a licence and supply agreement for the commercialisation of AVT03, under which Alvotech develops and manufactures the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.

There are three denosumab biosimilars already approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).

Over the past year, the FDA has accepted a number of denosumab biosimilar BLAs for review, including for: Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for February 2025.  Among the applications to be reviewed is a new indication for MSD’s Keytruda® (pembrolizumab) for patients with head and neck squamous cell carcinoma (HNSCC) as a preliminary treatment prior to surgery or as a treatment in combination with radiotherapy followed by Keytruda® alone.

The TGA has also updated its online list of prescription medicine registrations, with new registrations for the following expanded indications:

• MSD’s Keytruda® in combination with chemoradiotherapy for treatment of patients with high-risk locally advanced cervical cancer (FIGO 2014 Stage IB1-IIB and node-positive, or Stage III-IVA) (3 March 2025) and in combination with Astellas Pharma’s Padcev® (enfortumab vedotin) for first-line treatment of adults with locally advanced or metastatic urothelial carcinoma (24 February 2025)
• AstraZeneca’s Imfinzi® (durvalumab) as monotherapy for the treatment of adults with limited stage small cell lung cancer whose disease has not progressed following chemoradiation therapy (27 February 2025);
• Sanofi’s Dupixent® (dupilumab) for chronic obstructive pulmonary disease (25 February 2025);
• Astellas’ Padcev® (enfortumab vedotin) as monotherapy for treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed dealth-ligand-1 inhibitor (17 February 2025); and
• Bristol-Myers Squibb’s Opdivo® (nivolumab), in combination with chemotherapy, for the neoadjuvant treatment of adults with resectable non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, followed by Opdivo® as a single agent in the adjuvant setting after surgical resection (6 February 2025).

On 14 March 2025, the US Court of Appeals for the Federal Circuit upheld the ruling of the District Court for the Northern District of Virginia refusing Regeneron’s application for a preliminary injunction preventing launch of Amgen’s Pavblu®/APB 938 (aflibercept), biosimilar to Regeneron’s Eylea®.

The Appeals Court agreed with the District Court’s September 2024 ruling that Pavblu® did not infringe the asserted claims of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.  An application to the US Appeals Court by Regeneron for an injunction preventing Amgen from launching Pavblu® pending the substantive appeal had also been rejected in October 2024.  Amgen launched Pavblu® in the US immediately following the October 2024 decision.

The Appeals Court determined that the relevant claims of the US 865 patent required an aflibercept formulation that included a separate buffer component, but Amgen’s formulation did not contain any such separate buffer.  Instead, the evidence was that “Amgen had discovered a way to prepare and formulate” aflibercept in a manner that eliminates the need for a separate buffer as the aflibercept itself provides sufficient buffering capacity to stabilise the formulation.

The litigation against Amgen is part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024, litigation pending).

The Court’s refusal to grant a preliminary injunction against Amgen differs from decisions of the US District Court for the Northern District of Virginia to grant preliminary injunctions against Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the US 865 patent.  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  That appeal remains pending.  The aflibercept biosimilars of each of Samsung Bioepis, Formycon, Celltrion and Biocon are buffered.

Samsung Bioepis, Formycon and Celltrion are challenging the validity of Regeneron’s ‘865 patent before the USPTO, each having filed a petition for IPR (inter partes review) in November 2024, December 2024 and January 2025, respectively.

On 13 March 2025, Business Wire reported that Lumicera Health Services has entered into a purchase agreement with Anda, Inc., a Teva subsidiary, for unbranded ustekinumab, biosimilar to Janssen’s Stelara®.

Under the agreement, Lumicera’s discounted net acquisition cost is estimated to generate USD$120 million in annualised savings.  These savings will be accessed immediately through Lumicera’s pass-through, acquisition cost-plus model, not delayed through a rebated model.  Plan sponsors will save between USD$112,000 and $336,000 per patient per year compared to the annual per-patient cost of the reference product.

Earlier this year, on 21 February 2025, Alvotech and Teva announced the US launch of ustekinumab biosimilar, Selarsdi® (AVT04, ustekinumab-aekn for injection).  This followed Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which permitted US launch of the biosimilar from 21 February 2025.

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an agreement for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates.  The partnership was expanded in July 2023 to include four additional products.

On 13 March 2025, Celltrion announced that Steqeyma® (CT-P43), biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab), is now available in the US for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and paediatric psoriatic arthritis.

According to Celltrion, the wholesale acquisition cost (WAC) for Steqeyma® will be discounted by 85% compared with the current US WAC list price of Stelara®.

Steqeyma® received US FDA approval in December 2024 and was launched across 5 major EU countries in January 2025.

The US launch of Steqeyma® follows the US launches of Formycon/Fresenius Kabi’s Otulfi®/FYB202 (ustekinumab-aauz) in early March 2025, Sandoz/Samsung Bioepis’ Pyzchiva® (ustekinumab-ttwe) and Biocon’s Yesintek™ (ustekinumab-kfce/Bmab 1200) on 24 February 2025, Alvotech/Teva’s Selarsdi® (ustekinumab-aekn) on 21 February 2025 and Amgen’s Wezlana® (ustekinumab-auub) in early January 2025 (through Optum Health Solution’s private label subsidiary Nuvaila).

On 12 March 2025, New Zealand’s Pharmac announces that it has entered an agreement with Pfizer to fund a range of drugs from 1 April 2025, including its Besponsa® (inotuzumab ozogamicin) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL).

The agreement comes after Pharmac sought feedback on proposals to fund Besponsa® in December 2024.

On 12 March 2025, Australia’s Therapeutic Goods Administration (TGA) approved Amgen’s Uplizna® (Inebilizumab) for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.

Uplizna® has received previous approvals in other jurisdictions, including in the US (June 2020) and the EU (April 2022).

Inebilizumab was developed by Horizon Therapeutics before being acquired by Amgen in a $27.8 billion deal reached in December 2022.

On 12 March 2025, Australia’s Therapeutic Goods Administration approved three brands of Cipla’s liraglutide, making it the second approved generic to Novo Nordisk’s Saxenda® in Australia:

• CIPLA LIRAGLUTIDE: liraglutide 6 mg/mL solution for injection pre-filled pen (424371)
• LIRAGLUTIDE SANDOZ: liraglutide 6 mg/mL solution for injection pre-filled pen (449145)
• ARX-LIRAGLUTIDE: liraglutide 6 mg/mL solution for injection pre-filled pen (424370)

All three brands (one of which will be marketed by Sandoz and another by Arrotex), are indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

• ≥30 kg/m² (obese); or
• ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

The approval closely trails Sun Pharma’s generic liraglutide, which was approved in Australia across three brands for the same indication on 6 March 2025.  Cipla’s liraglutide was accepted for review by the TGA in October 2023.  Freyr’s Lobezyl® remains as the only other generic liraglutide currently under review by the TGA (accepted for review in September 2024).

On 12 December 2024, the Federal Court of Australia rejected Cipla’s challenge to the patent term extension of Novo Nordisk’s liraglutide formulation patent (AU 2004290862).  As a result, the term of the AU formulation patent remains due to expire in August 2025.  The Federal Court decision has not been appealed.

On 12 March 2025, Medical Dialogues reported that Intas Pharmaceuticals has received approval from India’s Subject Expert Committee functional under the Central Drug Standard Control Organisation (CDSCO) to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

The only currently authorised ophthalmic bevacizumab is Outlook Therapeutics’ Lytenava™ (ONS-5010, bevacizumab-vikg), which received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).  Outlook Therapeutics resubmitted a BLA to the US FDA for ONS-5010 in February 2025 after the FDA issued a complete response letter in 2023.

On 11 March 2025, Celltrion announced that its biosimilar infliximab for injection, currently known as Inflectra®, will be rebranded to Remdantry™ in Canada commencing on 1 April 2025.  The formulation, indications and dosages of Remdantry™ will remain the same as those for Inflectra®.

According to Celltrion, the rebrand reflects its “consolidation of both the intravenous (IV) and subcutaneous (SC) formulations” being directly commercialised by Celltrion in Canada in order to “provide healthcare professionals with a more streamlined prescribing experience”.

Inflectra®, biosimilar to Janssen’s Remicade®, was approved by Health Canada for the treatment of rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in January 2014 and for Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC) in June 2016.

Celltrion’s SC infliximab, Remsima™ SC, was approved by Health Canada for RA in January 2021 and for UC and Crohn’s disease in February 2024.

On 10 March 2025, Coherus BioSciences reported its fourth quarter and full year financial results for 2024, and announced that it will transfer approximately 50 employees to Intas Pharmaceuticals’ specialty unit, Accord BioPharma.  The move will reduce Coherus’ workforce by around 30%, leaving it with approximately 155 employees.

The divestiture follows Coherus’ December 2024 agreement with Accord’s parent company, Intas Pharmaceuticals, for the sale of its pegfilgrastim (Udenyca®), biosimilar to Amgen’s Neulasta®, under which Coherus received USD$483.4 million upfront, with up to USD$75 million in potential milestone payments based on net sales performance.  With the Udenyca® divesture, Coherus has now fully transition away from biosimilars, refocusing on its immune-oncology pipeline.

The addition of Udenyca® to Accord’s portfolio follows a number of important milestones achieved by the company for its biosimilar pipeline in recent months.  In February 2025, Intas and Bio-Thera reached an exclusive commercialisation and licence agreement for golimumab (BAT2506), biosimilar to J&J’s Simponi® and Simponi Aria®, under which Accord will be responsible for commercialising the product in the US and Bio-Thera will retain responsibility for development, manufacturing and supply.

In December 2024, the European Commission granted marketing authorisation for Accord Healthcare’s Imuldosa®, biosimilar ustekinumab, for a range of immune medicated inflammatory diseases.  Imuldosa® was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma.  In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals.  Imuldosa® will be launched in multiple regions, through Intas and its subsidiaries, including Accord Biopharma in the United States and Accord Healthcare in Europe, the UK, and Canada.

On 9 March 2025, Sun Pharma and Checkpoint Therapeutics announced that they have entered into an agreement for Sun Pharma to acquire Checkpoint Therapeutics.  Under the deal, Sun Pharma will own Checkpoint’s leading biopharmaceutical Unloxcyt™ (cosibelimab).

Unloxcyt™ received FDA approval in December 2024 for the treatment of adults with metastatic cutaneous squamous cell carcinoma or locally advanced cSCC who are not candidates for curative surgery or curative radiation.  The approval followed Checkpoint Therapeutics resubmission of its BLA to the FDA in July 2024.

According to the announcement, Checkpoint Therapeutics shareholders will receive a cash payment of USD$4.10 per share, but will be entitled to receive an additional USD$0.70 per share if cosibelimab is approved prior to certain deadlines in the European Union pursuant to the centralised approval procedure, or in Germany, France, Italy, Spain or the United Kingdom, subject to the terms and conditions in the agreement.

On 7 March 2025, Biocon Biologics announced the results of a Phase 3 study comparing Yesintek™ (biosimilar ustekinumab) with J&J/Janssen’s Stelara® in adults with moderate to severe chronic plaque psoriasis (PsO).  The study reportedly demonstrated equivalent efficacy, safety, immunogenicity and pharmacokinetics between the biosimilar and its reference product and continued efficacy and safety of switching from Stelara® to Yesintek™ from week 16 to week 52. Biocon intends to present the results at the March 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

Biocon launched Yesintek™ in the US in February 2025 following its approval in early December 2024 for adult patients with moderate to severe PsO who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis.

The European Commission granted marketing authorisation for Yesintek™ in February 2025 for the treatment of adults and children with plaque psoriasis and treatment of adults with psoriatic arthritis and Crohn’s disease.  The European approval followed a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 14 December 2024.

On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  Omlyclo® is approved as a 75 mg/0.5ml and 150mg/ml injection in a single pre-filled syringe for subcutaneous use.  The approval covers all US indications of Xolair®, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy and chronic spontaneous urticaria.

Omlyclo® was the first omalizumab biosimilar to be approved in Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).

On 30 January 2025, the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) was valid and infringed by Celltrion.  The UK Court judgment followed a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent.

Disputes between Novartis/Genentech and Celltrion regarding omalizumab are ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague), and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023.  In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid.  The oral proceedings in the opposition are due to take place in April 2025.

Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark have previously been reported to have omalizumab biosimilars under development.

On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with unresectable or advanced hepatocellular carcinoma (HCC).  The EC approval follows the CHMP’s positive opinion for the expanded indication in January 2025.

The same indication for the Opdivo®/Yervoy® combination is currently under review by the FDA, with BMS’ sBLA accepted in August 2024.  The FDA assigned a PDUFA goal date of 21 April 2025.

In December 2024, the European Commission approved Opdivo®/Yervoy® for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).  Applications for this indication are also pending in countries including the US (sBLA accepted in February 2025), Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024).

On 7 March 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved its Imfinzi® (durvalumab) 120 mg/2.4 mL and 500 mg/10 mL solution for infusion, for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).

In February this year, the EU’s CHMP recommended Imfinzi® for the new indication of treating adults with resectable NSCLC at high risk of recurrence, and in January, recommended Imfinzi® for LS-SCLC.

Also in February 2025, Australia’s TGA is accepted for review an indication expansion of Imfinzi® for muscle invasive bladder cancer, and was approved for LS-SCLC later thatd month.

In January 2025, the UK’s NICE recommended Imfinzi® in combination with chemotherapy (etoposide) plus either carboplatin or cisplatin for the treatment of adults with untreated extensive- SCLC

On 7 March 2025, the US District Court for the District of New Jersey ordered the dismissal of all claims and counterclaims in Amgen’s BPCIA patent infringement proceeding against Fresenius Kabi in relation to its denosumab biosimilar.  The order followed a stipulation by the parties as to their settlement of the litigation, which was filed with the Court on 4 March 2025.

Neither Amgen nor Fresenius Kabi have issued press releases about the settlement as at the date of this report and the terms on which the proceeding was settled, including the US launch date for Fresenius’ denosumab biosimilars, are currently unknown.

Amgen originally commenced proceedings against Fresenius Kabi on 4 October 2024 in the US District Court for the Northern District of Illinois (Eastern Division) alleging infringement of 33 US patents relating to denosumab.  The litigation followed Fresenius’ submission of an abbreviated Biologics Licence Application (aBLA) to the US FDA seeking approval to manufacture and sell its FKS518, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).  Fresenius’ aBLA for denosumab was accepted for review by the FDA on 27 May 2024.

In the context of the litigation, Amgen issued a subpoena to Cytiva subsidiary media supplier HyClone Laboratories requesting information including the full formulation of HyClone’s off-the-shelf cell culture supplement, HyClone™ Cell Boost™ 7a (CB7A).  Amgen has now withdrawn that subpoena given the settlement of the underlying litigation with Fresenius.

The BPCIA proceeding against Fresenius was one of five that Amgen had commenced in the US in relation to denosumab biosimilars, which were centralised in the US District Court for the District of New Jersey in February 2025.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).  Amgen also settled its US litigation against Celltrion in January 2025, permitting launch of Celltrion’s yet to be US-approved denosumab biosimilar from 1 June 2025.  The remaining court proceedings, against Samsung Bioepis (Ospomyv™/Xbryk™/SB16 approved February 2025, litigation commenced August 2024) and Accord/Intas (INTP23, litigation commenced November 2024), remain pending.

On 6 March 2025, Sun Pharma’s liraglutide became the first approved generic to Novo Nordisk’s Saxenda® in Australia.  The product was approved by Australia’s Therapeutic Goods Administration (TGA) across three brands:

• Benedo: liraglutide 6 mg/mL solution for injection pre-filled pen (428573);
• Liraglutide RBX: liraglutide 6 mg/mL solution for injection pre-filled pen (428571); and
• Liraglutide Sun: liraglutide 6 mg/mL solution for injection pre-filled pen (428572).

All three brands are indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

• ≥30 kg/m² (obese); or
• ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

Sun Pharma’s generic liraglutide was accepted for review by the TGA in January 2024.  There are currently two other generic liraglutide products being reviewed by the TGA: Freyr’s Lobezyl® (accepted for review in September 2024) and Cipla’s unnamed generic liraglutide (accepted for review in October 2023).

On 12 December 2024, the Federal Court of Australia rejected Cipla’s challenge to the patent term extension of Novo Nordisk’s liraglutide formulation patent (AU 2004290862).  As a result, the term of the AU formulation patent remains due to expire in August 2025.  The Federal Court decision has not been appealed.

Adalvo’s generic liraglutide was the first to be approved in the EU in June 2024, while Biocon’s liraglutide was the first generic approved in the UK in March 2024.  Teva Pharmaceuticals launched the first authorised generic liraglutide in the US in June 2024.

On 6 March 2025, the UK’s National Institute for Health and Care Excellence (NICE) opened a second consultation period in respect of the use of Eisai/Biogen’s Leqembi® (lecanemab) on the NHS in England for treating mild cognitive impairment (MCI) or mild dementia caused by Alzheimer’s disease.  The consultation follows NICE’s draft guidance in August 2024 determining that the benefits of lecanemab were too small to warrant making the drug available on the NHS for this indication.

The closing date for comments to be provided to the evaluation committee is 27 March 2025.  An evaluation committee meeting is scheduled for 14 May 2025, with publication of the decision expected in July 2025.

The UK was the first country in Europe to authorise Leqembi® in August 2024 for the treatment of MCI or mild dementia due to Alzheimer’s disease.  After NICE’s draft guidance against recommending making the drug available on the NHS for this indication, in February 2025, the Scottish Medicines Consortium (SMC) similarly declined to recommend reimbursement of Leqembi® for treating early-stage Alzheimer’s disease, citing uncertainties surrounding the drug’s clinical benefits and cost-effectiveness.

Leqembi® has been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  While Australia’s Therapeutic Goods Administration (TGA) has declined to approve Leqembi® (lecanemab) for the treatment for early Alzheimer’s Disease, in February 2025, the CHMP reaffirmed its positive recommendation for approval of this indication.

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered MSD an opportunity to licence patents owned by Halozyme in relation to a specific enzyme, known as Mdase.  Halozyme executives reportedly claimed during a recent investor conference that MSD’s subcutaneous (SC) version of Keytruda® (pembrolizumab) infringes those patents.

WSJ reports that a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the  enzyme variant are invalid.

The WSJ report follows petitions for post-grant review filed by MSD with the US Patent Trial and Appeal Board challenging the validity of seven of Halozyme’s US patents.  The petitions, which are currently pending, were filed between November 2024 and February 2025 in relation to: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758 and US 12060590.

In November 2024, MSD revealed positive topline results from its Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy.  The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).  At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, MSD announced an expected 2025 launch for SC Keytruda®.

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered MSD an opportunity to licence patents owned by Halozyme in relation to a specific enzyme, known as Mdase.  Halozyme executives reportedly claimed during a recent investor conference that MSD’s subcutaneous (SC) version of Keytruda® (pembrolizumab) infringes those patents.

WSJ reports that a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the  enzyme variant are invalid.

The WSJ report follows petitions for post-grant review filed by MSD with the US Patent Trial and Appeal Board challenging the validity of seven of Halozyme’s US patents.  The petitions, which are currently pending, were filed between November 2024 and February 2025 in relation to: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758 and US 12060590.

In November 2024, MSD revealed positive topline results from its Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy.  The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).  At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, MSD announced an expected 2025 launch for SC Keytruda®.

On 5 March 2025, Generics Bulletin reported that Amgen has launched Bkemv® (eculizumab-aeeb) in the US as the first available interchangeable biosimilar to Alexion’s Soliris®.

Bkemv® was approved by the FDA in May 2024 for the same indications as Soliris® (atypical haemolytic uremic syndrome (aHUS) and paroxysmal nocturnal haemoglobinuria (PNH)), and in the same dosage form and strength.

The timing of the US launch of Bkemv® was governed by a settlement reached by Amgen and Alexion in May 2020, permitting launch from 1 March 2025.  The only other eculizumab biosimilar currently approved in the US is Samsung Bioepis’ Epysqli® (SB12) (approved July 2024).

Amgen’s eculizumab biosimilar was approved in the EU as Bekemv® in April 2023.  On 19 March 2024, Alexion filed proceedings against Amgen in the Unified Patents Court (UPC), seeking provisional measures in relation to alleged infringement of EP3167888, concerning a method of treating PNH using eculizumab.  The UPC (June/July 2024) and the UPC Court of Appeal (December 2024) refused to grant preliminary injunctions against Amgen (and Samsung Bioepis) in relation to the sale of their eculizumab biosimilars in the EU.

On 5 March 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Celltrion from launching its biosimilar to Regeneron’s Eylea® (aflibercept) in the US without a licence from Regeneron.

In doing so, the Appeals Court affirmed the 28 June 2024 decision of the US District Court for the Northern District of West Virginia, finding that Celltrion infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

Celltrion’s CT-P42 (aflibercept) has not yet been approved in the US, although Celltrion filed an NDA with the FDA in June 2023.  CT-P42 (marketed as Eydenzelt®) was approved in Korea in May 2024 and received a positive CHMP opinion from the European Medicines Agency in December 2024.

The decision against Celltrion follows similar Appeals Court decisions in January 2025 upholding preliminary injunctions against Samsung Bioepis’ and Formycon’s aflibercept biosimilars, Opuviz™/SB15 (US approval received May 2024) and Ahzantive®/FYB203 (FDA-approved in June 2024), respectively.

The US District Court for the Northern District of West Virginia has also granted a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the same patent (US ‘865).  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  That appeal remains pending.

In October 2024, the Court of Appeals denied Regeneron’s application for an injunction against Amgen.  As a result, Amgen launched its aflibercept biosimilar, Pavblu®, in the US later the same month.

Samsung Bioepis, Formycon and Celltrion are challenging Regeneron’s ‘865 patent before the USPTO, each having filed a petition for inter partes review (in November 2024, December 2024 and January 2025, respectively).

On 4 March 2025, BeiGene announced that the US FDA has approved its Tevimbra® (tislelizumab), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) whose tumours express PD-L1 (≥1).

Tevimbra® has received a number of indication extensions in the past few months, including:

• in the US, in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal (G/GEJ) adenocarcinoma (January 2025); and
• in Australia, in combination with platinum-based chemotherapy, for the first-line treatment of patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (December 2024).

In December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) recommended PBS-listing of Tevimbra® for oesophageal squamous cell carcinoma.  In the same month, BeiGene announced New Zealand approval of Tevimbra® in various monotherapy and combination therapy indications.  Tevimbra® also recently received EU approval as combination therapy with chemotherapy for the first-line treatment of oesophageal squamous cell carcinoma and G/GEJ adenocarcinoma (November 2024).

On 4 March 2025, AbbVie announced that Skyrizi® (risankizumab) is now available in Canada for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.

The UC indication was approved by Health Canada in October 2024.  It is the fourth indication approved for Skyrizi® in Canada following approvals for moderately to severely active Crohn’s disease (October 2022), active psoriatic arthritis (March 2022) and moderate to severe plaque psoriasis (March 2019).

Skyrizi® was approved for treatment of UC by the European Commission in July 2024, and by the US FDA in June 2024.

On 4 March 2025, NeurologyLive reported that the US FDA has approved an expanded indication of Alexion/AstraZeneca’s Soliris® (eculizumab) to include both adult and paediatric patients 6 years of age or older with generalised myasthenia gravis (gMG) who are antiacetylcholine receptor (AChR) antibody positive.

This approval means Soliris® (eculizumab) is the first and only approved treatment in the US for paediatric patients living with the gMG.

Soliris® was approved for the same indication in the EU in July 2023.

On 3 March 2025, Fresenius announced the US launch of Otulfi®/FYB202 (ustekinumab-aauz), biosimilar to J&J/Janssen’s Stelara®.

FYB202/Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024.  It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling US launch of FYB202 “no later than 15 April 2025”.  This was followed by a settlement in March 2024 regarding the commercialisation of FYB202/Otulfi® in Europe and Canada.  The agreed launch dates for FYB202 in the UK and Canada remain confidential.

The US launch of Otulfi® follows those of Sandoz’s Pyzchiva® and Biocon’s Yesintek™ on 24 February 2025, Alvotech/Teva’s Selarsdi® on 21 February 2025 and Amgen’s Wezlana® in early January 2025 (through Optum Health Solution’s private label subsidiary Nuvaila).

On 3 March 2025, Eisai and Biogen announced that Australia’s Therapeutic Goods Administration (TGA) has confirmed its initial decision to decline the approval of Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease (AD).  Eisai is “extremely disappointed and surprised by the TGA’s decision” and is exploring its options, including the possibility of seeking a review of the TGA’s decision by Australia’s Administrative Review Tribunal.

The TGA issued a decision in October 2024 not to approve Leqembi® for the treatment of patients with mild Alzheimer’s dementia (early Alzheimer’s disease) and mild cognitive impairment (MCI) due to Alzheimer’s disease.  The decision was based on the TGA’s opinion that demonstrated efficacy of the drug did not outweigh the safety risks associated with use of lecanemab.  Eisai subsequently requested reconsideration of the decision.

As part of the reconsideration, the TGA proposed a narrowed therapeutic indication but ultimately no indication could be agreed upon by the TGA and Eisai.

Leqembi® has been approved for MCI and mild dementia due to Alzheimer’s disease in the US,  Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  In February 2025, the CHMP reaffirmed its positive recommendation for approval of lecanemab for MCI and mild dementia due to Alzheimer’s disease.

On 3 March 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has accepted for review their aBLA for two new denosumab biosimilars referencing Amgen’s Prolia® and Xgeva®.   The FDA has assigned a target action date in Q4 2025.

The biosimilars are being co-developed, with mAbxience responsible for the development and manufacturing and Amneal pursuing regulatory approval and having exclusive US commercialisation rights.  The two companies also collaborate on Alymsys®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), which  was approved in the US in April 2022.

There are three denosumab biosimilars approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).

There are also a number of denosumab biosimilars in the wings, with the FDA having accepted applications for review, including for: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

On 3 March 2025, Celltrion announced that it has received US FDA approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.  The approval follows European approval of Celltrion’s denosumab biosimilars in February 2025.

Stoboclo® and Osenvelt® are the third denosumab biosimilars to be approved in the US, trailing Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).

Celltrion filed its aBLA for CT-P41 in the US in December 2023.  However, in May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation was settled in January 2025, allowing Celltrion to launch its denosumab biosimilars in the US from 1 June 2025.

On 3 March 2025, Genevant Sciences and Arbutus Biopharma announced that they have jointly filed five international lawsuits seeking to enforce patents protecting their lipid nanoparticle (LNP) technology against Moderna and certain affiliates.  Genevant and Arbutus are seeking injunctions and damages or royalties in respect of Moderna’s Spikevax® Covid-19 mRNA vaccine, and also potentially Moderna’s RSV vaccine mRESVIA®, which Moderna “has represented use the same LNP technology” as claimed in Genevant/Arbutus’ patents.

The five lawsuits were filed in the following jurisdictions:

• Canada (File No. T-704-25), alleging infringement of CA2721333;
• Japan (Case No. 2025 (Wa) 70079), alleging infringement of JP5475753;
• Switzerland, alleging infringement of EP2279254;
• Unified Patent Court (UPC) (Case 10280/2025), alleging infringement of EP2279254; and
• UPC (Case 10284/2025), alleging infringement of EP4241767.

Together, the enforcement actions target 30 countries, with the UPC actions seeking relief in: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland/Liechtenstein, and Turkey.

The Court filings follow litigation between the parties underway in the US District Court for the District of Delaware (1:22-cv-00252), which is scheduled for trial in September 2025.  In those proceedings, Genevant and Arbutus allege that Moderna infringes six US patents relating to LNP technology: 11141378, 8058069, 8492359, 8822668, 9364435 and 9504651.

The five lawsuits were commenced in the same week as two US Moderna patents to Spikevax® were invalidated by the PTAB.  The PTAB invalidation followed IPRs filed by Pfizer and BioNTech in 2023 (IPR2023-01358 and IPR2023-01359) against two patents to the Moderna coronavirus vaccine (US10702600 and US10933127) respectively.  According to Pfizer/BioNTech media releases, the decision was delivered by PTAB on 6 March 2025 and is currently under seal.  The PTAB decision is appealable to the Federal Circuit.

Moderna sued Pfizer and BioNTech in the District Court of Massachusetts in 2022 alleging infringement of 3 patents.  The PTAB decision relates to 2 of the in-suit patents.

On 1 March 2025, Sandoz’s high-concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) 100mg/mL (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications.

This follows PBS-listing of Hyrimoz® 100mg/mL (40 mg/0.4 mL injection, 2 x 0.4 mL pen) formulation in January 2025.  High concentration Hyrimoz® was first approved in Australia in May 2024 and was recommended by Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) in its July 2024 meeting.

There are a number of other high-concentration (100mg/mL) adalimumab biosimilars approved in Australia, including Samsung Bioepis’ Hadlima® (February 2023), Cipla/Alvotech’s Ciptunex®/Adalicip® (September 2022) and Celltrion’s Yuflyma® (March 2022).

On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of Bristol Myers Squibb’s US patents relating to methods of treatment using nivolumab and ipilimumab for cancer generally (US 9856320), melanoma (US 10174113) and colorectal cancer (US 11332529).

Amgen currently has a biosimilar to BMS’ Opdivo® (nivolumab) under development, having enrolled patients in a Phase 3 study evaluating the efficacy, safety, and immunogenicity of Amgen’s ABP 206 compared with Opidvo®.  The study is expected to be completed in 2027.

BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) combination has been approved in Europe for certain colorectal cancer patients (December 2024) and is under evaluation for the same indication in the US (sBLA accepted in February 2025), Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024).  The combination therapy is also being considered for treatment of hepatocellular carcinoma including in the US. Expansion of approval to this indication in Europe was recommended in January 2025.

At its February 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended expanded therapeutic indications for 16 medicines, including the following six biopharmaceuticals.

The CHMP adopted a positive opinion for an extended indication of Janssen’s Stelara® (ustekinumab) to children with Crohn’s disease weighing at least 40 kg.  The new indication will apply to Stelara® concentrate for solution for infusion and solution for injection in vial or pre-filled syringe.

Janssen also received positive CHMP opinions for Darzalex® (daratumumab), with the removal of a limitation that adult patients with newly diagnosed multiple myeloma to be treated must be “eligible for autologous stem cell transplant”, and Tremfya® (guselkumab), to include treatment of adults with ulcerative colitis.

AstraZeneca’s Imfinzi® (durvalumab) has received a positive recommendation for the new indication of treating adults with resectable NSCLC at high risk of recurrence.

The CHMP also adopted positive opinions for indication expansions to:

• Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), to include treatment of adults with unresectable or metastatic HR-positive HER2-low or -ultralow breast cancer; and
• Roche’s Columvi® (glofitamab), to include treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified who are ineligible for autologous stem cell transplant.

In addition, after re-examining its initial opinion at MSD’s request, the CHMP confirmed its positive recommendation for an expanded indication for MSD’s Keytruda® (pembrolizumab) to include patients with unresectable non-epithelioid malignant pleural mesothelioma.  The positive recommendation was initially adopted in November 2024.

On 28 February 2025, Biocon announced that it has launched its liraglutide products in the UK.  The products are generic versions of Novo Nordisk’s Victoza®, to treat type 2 diabetes, and Saxenda®, used in the treatment of weight management.  Biocon’s products are marketed under the brand names Liraglutide Biocon (gVictoza®) and Biolide (gSaxenda®).

Biocon’s liraglutide became the first UK-approved generic to Novo Nordisk’s liraglutide products in March 2024.

In December 2024, Biocon and its European partner, Zentiva, received approval for liraglutide in the European Union.  The first EU-approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024.  Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.

On 28 February 2025, Regeneron announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation of Lynozyfic® (linvoseltamab) for treatment of adults with relapsed and refractory multiple myeloma (R/R MM) who have received at least three prior therapies.  Regeneron’s marketing authorisation application for linvoseltamab was accepted by the EMA in February 2024.

Conditional marketing authorisations are granted to medicines which address unmet medical needs.  Less comprehensive clinical data than is normally required may support a conditional marketing authorisation where the benefit of immediate availability of the drug outweighs the risk inherent in the fact that additional data are still required.

The positive recommendation for linvoseltamab was based on data from the “LINKER-MM1” trial, which evaluated linvoseltamab in adults with R/R MM.

Earlier in February 2025, the FDA accepted Regeneron’s resubmitted BLA for linvoseltamab.  The FDA’s target action date is 10 July 2025.

On 28 February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for Leqembi® (lecanemab) for early Alzheimer’s disease.

In late January 2025, the European Commission had asked the CHMP to re-consider the positive opinion granted for Leqembi® in November 2024 following safety information that had since become available.

The CHMP’s reaffirmed recommendation for approval means that the EC will now resume its decision-making process for lecanemab’s marketing authorisation.

The UK was the first country in Europe to authorise Leqembi® in August 2024 for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease.  However, in the same month, the UK’s NICE determined that the benefits of lecanemab were too small to warrant making the drug available on the NHS.  Similarly, earlier in February 2025, the Scottish Medicines Consortium (SMC) declined to recommend reimbursement of Leqembi® for treating early-stage Alzheimer’s disease, citing uncertainties surrounding the drug’s clinical benefits and cost-effectiveness.

On 28 February 2025, Outlook Therapeutics announced that it has resubmitted its Biologics Licence Application (BLA) to the US FDA for ONS-5010 (Lytenava™, ophthalmic bevacizumab-vikg) for the treatment of wet AMD.

The resubmission is based on positive results of the NORSE EIGHT clinical trial, announced in January 2025, which are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibizumab) in terms of efficacy and safety.  The study was conducted following Outlook’s receipt of a complete response letter (CRL) from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials.  Additional chemistry, manufacturing and controls (CMC) information requested by the FDA has also been included in the resubmission.

Lytenava™ was approved in the UK for wet AMD in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).  The UK approval followed marketing authorisation granted to Lytenava™ in the EU in May 2024.  Lytenava™ is the first authorised ophthalmic formulation of bevacizumab in the EU.

On 26 February 2025, Regeneron announced that the US FDA has accepted for review the resubmission of the BLA for odronextamab for the treatment of relapsed/refractory follicular lymphoma (R/R FL).  The FDA’s PDUFA target action date is 30 July 2025.

Regeneron’s odronextamab BLA for R/R FL or R/R diffuse large B-cell lymphoma (DLBCL) was first accepted by the FDA for priority review in September 2023, with a target action date of 31 March 2024.  In March 2024, the FDA issued complete response letters (CRLs), one for each indication, relating to enrolment status in confirmatory trials evaluating the medicine.  According to Regeneron, the CRLs did not identify any issues regarding efficacy, safety, trial design or manufacturing of odronextamab.

Regeneron’s BLA resubmission for R/R FL was based on achievement of the FDA-mandated enrolment target for the OLYMPIA-1 Phase 3 confirmatory trial of odronextamab in R/R FL.

Odronextamab was approved in Europe in August 2024, as Ordspono™, for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy.

On 26 February 2025, CSL announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Andembry® (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and certain paediatric patients.

Switzerland is the fifth jurisdiction to approve Andembry®, and all other approvals have occurred this year.  Australia was first to approve Andembry® in January 2025, closely followed by the UK (January 2025), EU (February 2025) and Japan (February 2025).

Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug accepted in December 2023.  According to CSL, Andembry® is also under review in Canada.

On 25 February 2025, MSD published its 2024 Annual Report, which revealed the company’s expectation that Keytruda® (pembrolizumab) will be selected in 2026 for government price setting under the US Inflation Reduction Act 2022 (IRA).  According to MSD, such price setting would become effective on 1 January 2028, with US sales of Keytruda® likely declining after that time.

In June 2023, MSD commenced litigation against the US Government in connection with the IRA, alleging, amongst other things, that the “Drug Price Reduction Program” legislated by the Act is unconstitutional.

Novartis has also sued the US Government in relation to the IRA (in September 2023), arguing that the negotiations are “an unprecedented and unconstitutional attempt to compel the nation’s drug manufacturers to sell their products at prices dramatically below their market value”.

On 25 February 2025, MSD, announced that the US FDA has accepted for priority review a Biologics Licence Application (sBLA) for Keytruda® (pembrolizumab).  The sBLA is for patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) as neoadjuvant treatment, then continued as adjuvant treatment in combination with standard of care radiotherapy, with or without cisplatin, and then as a single agent.  The FDA’s target action date is 23 June 2025.

The sBLA is based on results of the Phase 3 KEYNOTE 689 trial.  According to MSD, an interim analysis shows that the results demonstrate significant improvement in event-free survival in the neoadjuvant and adjuvant setting for pembrolizumab in earlier stages of HNSCC.

The FDA review of the sBLA is being conducted under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners.  Regulatory authorities in Australia, Brazil, Canada, Israel and Switzerland will also be reviewing the application.

Keytruda® is approved as monotherapy and in combination regimens for certain patients with metastatic or unresectable, recurrent HNSCC in countries including the US, Europe, China, Japan, Australia and New Zealand.

On 25 February 2025, Sanofi announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Sarclisa® (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).

The combination therapy was approved in a number of jurisdictions in January 2025, including China, the UK, and the European Union.  It was also approved in the US in September 2024.

In November 2024, Sanofi succeeded in a UK appeal against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM).

On 25 February 2025, Formycon and Klinge Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ahzantive®/FYB203 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®.  Ahzantive® is approved in the UK for nAMD and other retinal disease including diabetic macular oedema (DME), visual impairment due to myopic choroidal neovascularisation (CNV) and macular oedema following retinal vein occlusion (RVO).

FYB203 received a positive opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP) in November 2024 (under the brand names Ahzantive® and Baiama®) and was granted marketing approval by the European Commission in January 2025.

FYB203 was approved in the US in June 2024, where it is subject to a preliminary injunction granted in June 2024, and upheld at the end of January 2025, resulting from a patent infringement proceeding brought by Regeneron in November 2023.

Formycon developed FYB203 and Klinge holds the exclusive global commercialisation rights.  In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 in Europe (excluding Italy) and Israel.

On 24 February 2025, Sandoz announced the US launch of Pyzchiva® (ustekinumab-ttwe), biosimilar to J&J/Janssen’s Stelara®.  On the same date, Biocon Biologics announced the US launch of Yesintek™ (ustekinumab-kfce/Bmab 1200).

Pyzchiva® was developed by Samsung Bioepis and is commercialised by Sandoz in the US pursuant to a deal entered into in September 2023.  The US FDA approved Pyzchiva® in July 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Yesintek™ was approved in the US in early December 2024 for the same indications.

The timing of both the Pyzchiva® and Yesintek™ launches was governed by settlement and licence agreements between Janssen and the biosimilar sponsors to resolve US litigation/Inter Partes Review Petitions.  Samsung Bioepis entered an agreement in July 2023 (announced in November 2023), permitting launch of Pyzchiva® in the US from 22 February 2025.  Biocon entered its settlement with Janssen in February 2024, permitting launch of Yesintek™ from February 2025.

The US-launches of Pyzchiva® and Yesintek™ follow those of Alvotech/Teva’s Selarsdi® on 21 February 2025 and Amgen’s Wezlana® in early January 2025 (through Optum Health Solution’s private label subsidiary Nuvaila).

On 24 February 2025, Johnson & Johnson (J&J) and Janssen Biotech filed a complaint in the US District Court for the District of New Jersey alleging that Samsung Bioepis has breached a settlement and licence agreement entered in July 2023 (announced in November 2023), permitting Samsung Bioepis to launch Pyzchiva® (SB17) (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025.  The settlement agreement resolved pending US patent litigation between the companies at the time it was signed.

The complaint, filed the same day on which the US launch of Pyzchiva® was announced, claims that Samsung Bioepis has entered into an unauthorised sublicence with a private label provider.  While the private label provider has not been publicly identified, it is described in J&J’s complaint as a member of a vertically integrated health conglomerate that includes a health insurer, health care provider, pharmacy chain and pharmacy benefits manager (PBM).  According to J&J, the 2023 settlement agreement did not permit Samsung Bioepis to authorise the private label provider to launch in the US an additional, private label version of Pyzchiva®.

J&J is seeking a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar and compensatory damages “in an amount to be determined at trial”.  Samsung Bioepis has not yet filed a defence.

Pyzchiva® was approved by the US FDA in July 2024 for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  It is commercialised in the US (and Europe and Canada) by Sandoz pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

J&J has previously entered into ustekinumab settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Celltrion (US licence date of 7 March 2025) and Fresenius Kabi and Formycon (US licence date no later than 15 April 2025).

Janssen and Samsung Bioepis remain in patent infringement litigation in Australia, with the trial scheduled in June 2025.  In October 2024, the Canadian Federal Court dismissed a motion by Janssen to add an infringement counterclaim in proceedings brought by Samsung Bioepis to invalidate one of Janssen’s Canadian patents covering ustekinumab.

On 24 February 2025, Celltrion announced that the European Commission has approved Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab).  Avtozma® is approved for all indications of RoActemra®, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA).

Celltrion’s Avtozma® is the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

Earlier this month, Celltrion’s SC tocilizumab formulation was approved in Korea, following Korean approval of IV tocilizumab in 200mg/10ml and 400mg/20ml formulations in December 2024.

In January 2025, Avtozma® became the third tocilizumab biosimilar approved in the US, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

Following the FDA’s decision on 21 February 2025 to remove Novo Nordisk’s semaglutide products (Ozempic® and Wegovy®) from the Drug Shortages List, the regulator has been sued by the Outsourcing Facilities Association, a compounding industry group, and FarmaKeio Superior Custom Compounding, a Texas based compounding pharmacy.

The Complaint, lodged on 24 February 2025, alleges that the FDA’s decision was arbitrary and reckless and is contrary to law.

In removing semaglutide from the Drug Shortages List, the FDA confirmed it will take action from 22 April 2025 against state-licensed pharmacies which sell compounded versions of the drug and from 22 May 2025 against outsourcing facilities which compound, distribute or sell semaglutide copies.

Novo Nordisk has argued that semaglutide is challenging to produce safely due to its complex formulation involving yeast-based recombinant DNA technology.  Furthermore, compounded versions lack clinical testing, exhibit different impurity profiles, and have raised safety concerns.  This is consistent with alerts issued by the FDA to US healthcare providers in July 2024 in relation to risks associated with compounded semaglutide, and the position taken by the Australian Therapeutic Goods Administration (TGA) which has banned compounded copies of Ozempic® since 1 October 2024 due to serious safety concerns.

BMS has announced that the FDA has accepted a supplemental biologics licence application (sBLA) for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment option for adult and paediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC).  The FDA granted the application Breakthrough Therapy Designation and Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of 23 June 2025.

The Opdivo®/Yervoy ® combination was approved for these indications in Europe in December 2024, and similar applications are pending elsewhere.

The second quarter of 2025 should also see the result of the FDA’s consideration of the sBLA for the same combination therapy for the treatment of unresectable hepatocellular carcinoma, with a PDUFA goal date of 21 April 2025.  Expansion of approval to this indication in Europe was recommended in January 2025.

On 21 February 2025, Alvotech and Teva announced the US launch of Selarsdi® (AVT04, ustekinumab-aekn for injection), biosimilar to J&J/Janssen’s Stelara®.

This follows Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which permitted US launch of the biosimilar from 21 February 2025.  Selarsdi® is now the second biosimilar available in the US, following the launch of Amgen’s Wezlana® in January 2025 through Optum Health Solution’s private label subsidiary Nuvaila.

Selarsdi® was first approved by the FDA in April 2024 in 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection for treating psoriatic arthritis and plaque psoriasis.  In October 2024, the FDA approved an additional presentation for 130 mg/26 ml in a single-dose vial for intravenous infusion and expanded the label to include treatment of adults with Crohn’s disease and ulcerative colitis.

The FDA has granted Selarsdi® a provisional determination of interchangeability following the expiry of exclusivity for Wezlana® (the first interchangeable biosimilar) on 30 April 2025.

AVT04 was launched in Canada in Q1 2024 (marketed by JAMP as Jamteki®), in Europe in July 2024 (marketed by STADA as Uzpruvo®) and in Japan in May 2024 (marketed by Fuji Pharma as Ustekinumab BS (F)).

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates.  The partnership was expanded in July 2023 to include four additional products.

On 21 February 2025, the FDA announced that the US semaglutide injection product shortage has resolved, such that semaglutide can now be removed from the drug shortages list.  The FDA has confirmed it will take action from 22 April 2025 against state-licensed pharmacies which sell compounded versions of the drug and from 22 May 2025 against outsourcing facilities which compound, distribute or sell semaglutide copies.

Semaglutide injection products, namely Novo Nordisk’s popular weight-loss drug Wegovy® and its diabetes drug Ozempic®, were first added to the FDA’s drug shortages list in March 2022 and August 2022, respectively.  While it was announced in October 2024 that all doses of Wegovy® and Ozempic® were available in the US, the FDA has continued to monitor the availability of the drugs.  Based on information provided by Novo Nordisk, the FDA has now concluded that Novo Nordisk’s supply of semaglutide is currently meeting or exceeding demand and it has sufficient reserves to meet or exceed projected demand.

On 21 February 2025, Korean Economic Daily reported that Samsung Bioepis has succeed in a patent dispute regarding Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept).  Regeneron had commenced the proceeding in January 2023 in the Seoul Central District Court seeking to prevent Samsung Bioepis from producing and selling Afilivu® in Korea.  However, the Court has now ruled in Samsung Bioepis’ favour, clearing the way for its biosimilar in Korea, at least for now.

Samsung Bioepis may face further hurdles if the decision is appealed or if Regeneron prevails in a second injunction application filed by Regeneron with the same Court last week.  The second injunction application requests a sales ban on Afilivu® in Korea for “other reasons” not cited in the KED report.

Afilivu® was the first aflibercept biosimilar approved in Korea in February 2024.  In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024.

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching its aflibercept biosimilar in the US without a licence from Regeneron.  This ruling affirmed an earlier decision of the US District Court for the Northern District of West Virginia in June 2024, finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

On 20 February 2025, GSK announced that China’s National Medical Products Administration (NMPA) has accepted for review a new drug application for the use of Nucala® (mepolizumab) as add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.  According to GSK, if approved, Nucala® could be the first approved biologic with monthly dosing for patients with COPD.

Nucala® has been approved in China for a number of indications, including as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) (January 2025), and as add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older (January 2024).

In December 2024, GSK announced that the US FDA accepted for review data to support a new indication for the use of Nucala® as add-on maintenance treatment for patients with COPD with an eosinophilic phenotype.

On 20 February 2025, CSL announced that its Andembry® (garadacimab) has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in subcutaneous 200mg injection pens for the prevention of acute attacks of hereditary angioedema (HAE).

This approval makes Japan the fourth jurisdiction to approve Andembry® (previously referred to as CSL312).  Australia was the first to approve Andembry® globally in January 2025, closely followed by the UK (January 2025) and the EU (February 2025).

Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug accepted in December 2023.  According to CSL, Andembry® is also under review by regulatory agencies in Switzerland and Canada.

On 20 February 2025, Genmab announced that Japan’s Ministry of Health, Labour and Welfare has approved Epkinly® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have received two or more prior lines of therapy.

Epkinly® (marketed as Tepkinly® in the EU) was co-developed by Genmab and AbbVie, and the companies share commercial responsibilities in the US and Japan.

In January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection, indicated for the treatment of adult patients with R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.  This followed provisional approval of the same formulation and indications by Australia’s Therapeutic Goods Administration (TGA) in early January 2025.

On 20 February 2025, Bayer announced that Health Canada has approved Eylea® HD (aflibercept injection, 8mg) in a pre-filled syringe with integrated OcuClick™ dosing system for the treatment of nAMD and diabetic macular oedema (DME).

Eylea® 8mg was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both low (2mg) and high dose Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

High dose Eylea® pre-filled syringe (OcuClick™) has also been approved in Australia (October 2024) and Europe (September 2024).

High dose Eylea® for intravitreal injection is approved for nAMD and DME in the EU (January 2024), Japan (January 2024), the UK (January 2024) and Australia (June 2024).  On 10 February 2025, Bayer announced that it submitted a marketing authorisation application to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months with Eylea™ 8 mg for nAMD and DME.

On 19 February 2025, Celltrion announced that the European Commission has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.

Celltrion’s denosumab biosimilars are the third to be approved in Europe, following approval of Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).

Stoboclo® and Osenvelt® received positive opinions from the EMA’s CHMP in December 2024.

The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

Celltrion filed an abbreviated Biologics Licence Application for CT-P41 in the US in December 2023.  However, in May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation was settled in January 2025, allowing Celltrion to launch its denosumab biosimilars in the US from 1 June 2025.

On 19 February 2025, Shanghai Henlius Biotech announced that its HANBEITAI, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has received marketing approval from Bolivia’s Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) under the trade name Longiva™.

This is the drug’s first approval outside China (approved December 2021), making it the fourth self-developed product from Shanghai Henlius Biotech to be marketed overseas.

The first bevacizumab biosimilar was approved in the US in September 2017 and in Europe in January 2018.

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the month of January.  Among the applications for new medicines to be reviewed is GSK’s Blenrep® (belantamab mafodotin) for the treatment of patients with multiple myeloma that has returned or did not respond to treatment.

Meanwhile, AbbVie’s Elahere® (mirvetuximab soravtansine) has been accepted for review for the treatment for adult patients with a specific type of ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy.  Elahere® received EU approval for this indication in November 2024.

Applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:

• AstraZeneca’s Imfinzi® (durvalumab) for muscle invasive bladder cancer. Imfinzi® is already also under review by the TGA for the treatment of patients with limited-stage small cell lung cancer;
• Takeda’s Adcetris® (brentuximab vedotin) for the treatment of adult patients with previously untreated Hodgkin Lymphoma, in combination with other anti-cancer drugs;
• Janssen’s Darzalex SC® (daratumumab) for the treatment of patients with newly-diagnosed multiple myeloma who are ineligible for a stem cell transplant, and high-risk smouldering multiple myeloma; and
• Janssen’s Tremfya® (guselkumab) for the treatment of children aged 6 years and older with moderate to severe plaque psoriasis who are eligible for systemic (whole-body) therapy or phototherapy (ultraviolet light therapy.

On 18 February 2025, Celltrion announced that the European Commission has approved Eydenzelt® (CT-P42), biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).  Eydenzelt® received a positive opinion from the CHMP in December 2024.

Eydenzelt® is the fifth aflibercept biosimilar to be approved in the EU, following: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama®/Ahzantive® (January 2025).  Amgen’s Pavblu® and Skojoy® received positive recommendations for marketing approval from the CHMP in January 2025, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.

Celltrion filed an NDA with the FDA in June 2023 for Eydenzelt® and received Korean approval for the product in May 2024.

On 18 February 2025, Biocon Biologics announced that the European Commission has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  Yesintek® is indicated for the treatment of adults and children with plaque psoriasis and treatment of adults with psoriatic arthritis and Crohn’s disease.  The marketing authorisation approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 14 December 2024.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen, which enables Biocon to commercialise Bmab 1200/Yesintek® in Europe, the United Kingdom, Canada and Japan.  The agreed launch dates for these jurisdictions remain confidential.

There are a number of ustekinumab biosimilars being marketed in the EU, with three launched during 2024, STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024.  Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).  Bio-Thera’s MAA for BAT2206 (ustekinumab) was also accepted by the EMA in July 2024.

Yesintek® was approved in the US in early December 2024 for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.  In January 2025, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved Biocon’s subcutaneous ustekinumab (Bmab 1200).

Biocon can launch Yesintek® in the US in February 2025 as agreed in a settlement deal between Biocon and J&J entered in February 2024.

On 18 February 2025, Merus announced that the FDA has granted Breakthrough Therapy Designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment of adults with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (r/m HNSCC).

This is the second BTD for petosemtamab following the same designation given in May 2024 for treatment of patients with r/m HNSCC whose disease has progressed following chemotherapy and an anti-PD-1 antibody.  Petosemtamab received Fast Track designation for this indication in August 2023.

On 18 February 2025, Galderma announced that Nemluvio® (nemolizumab) for subcutaneous administration has been approved in the UK and Switzerland for two indications:

• moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at least 30kg, who are candidates for systemic therapy; and
• moderate-to-severe prurigo nodularis in adults who are candidates for systemic therapy.

According to Galderma, these are the first approvals from countries within the Access Consortium framework, an international collaborative initiative comprised of regulatory authorities which work together to address shared challenges.  Nemluvio® is currently under review in Australia and Singapore, the remaining members of the Access Consortium, with decisions expected later this year.

Just four days earlier, Galderma announced the approval of Nemluvio® in the EU for the same indications.  Nemluvio® has also been approved in the US for moderate to severe atopic dermatitis (December 2024) and prurigo nodularis (August 2024).

On 18 February 2025, Regeneron and Sanofi announced that the US FDA has accepted their sBLA for priority review of Dupixent® (dupilumab) for the targeted treatment of bullous pemphigoid (BP).  The FDA’s decision is expected by 20 June 2025.  If approved, Dupixent® will be the first and only targeted medicine to treat BP in the US.

The FDA is also reviewing a Dupixent® sBLA for chronic spontaneous urticaria (CSU), with action due on 18 April 2025.

Despite the appearance of “business as usual”, Regeneron’s litigation against Sanofi in the US District Court for the Southern District of New York remains on foot, in which Regeneron alleges Sanofi violated the terms of their Dupixent® collaboration agreement.

On 18 February 2025, Alvotech and Teva announced that the US FDA has accepted for review a Biologics Licence Application (BLA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg).  The companies expect that regulatory approval will be obtained in Q4/2025.

Alvotech and Teva’s partnership commenced in August 2020 for the commercialisation of 5 biosimilars in the US and has subsequently expanded.  In addition to AVT06, Alvotech is also developing AVT29, biosimilar to Regeneron’s Eylea HD® (aflibercept, 8 mg).  Teva also holds commercialisation rights for AVT29 in the US.

There are currently five aflibercept (2 mg) biosimilars approved in the US: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu™ (August 2024), Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024).  Amgen’s Pavblu® was the first aflibercept biosimilar to be launched in the US in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.

On 15 August 2024, Alvotech and its European commercialisation partner, Advanz Pharma announced that the European Medicines Agency (EMA) had accepted a Marketing Authorisation Application (MAA) for AVT06, with marketing authorisation expected to be granted in Q3 2025.

On 17 February 2025, Boan Biotech announced that the Journal of Bone Oncology published Phase III trial results for its biosimilar denosumab (Boluojia®/BA1102, formerly code-named LY01011), demonstrating comparable efficacy and safety to reference product, Amgen’s Xgeva®.  Boluojia® is reported to have met all primary and secondary endpoints.

Boluojia® was approved for marketing in China in May 2024 for the treatment of giant cell tumours of bone, following the approval of Mabwell’s Maiweijian™ in April 2024, which was the first Chinese approved denosumab biosimilar.

The Australian Financial Review reports that on 17 February 2025, Novo Nordisk confirmed that Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® (semaglutide) as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in overweight and obese adults with established cardiovascular disease (CVD) and without established Type 1 or Type 2 diabetes.  The indication extension was registered by the TGA on 19 December 2024.

Novo Nordisk obtained US approval for the same indication of Wegovy® in March 2024.  In July 2024, the CHMP adopted a positive opinion for an update to the label for Wegovy® in Europe to reflect a risk reduction of MACE in adults with established CVD and either overweight or obesity without diabetes.

On 17 February 2025, Formycon announced that it will be prematurely terminating the “Lotus” Phase 3 trial of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab).  According to Formycon, based on “intensive scientific dialogue” with the US FDA, it has concluded that the Phase 3 study is no longer necessary for the development and US approval of FYB206.  Instead, Formycon proposes to rely on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.

The Phase 1 trial was commenced in June 2024 and is comparing the pharmacokinetics, safety and tolerability of FYB206 with Keytruda® in malignant melanoma.  The Lotus Phase 3 trial was commenced in July 2024 to compare the efficacy and safety of FYB206 with Keytruda® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).

In October 2024, Formycon announced that results of a comparative analytical evaluation of FYB206, published in Drugs in R&D, showed FYB206 to be structurally and functionally “highly similar” to Keytruda®.

Other pembrolizumab biosimilars in clinical trials include Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced 25 July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 commenced in April 2024 (Ph 3)/May 2024 (Ph 1)).  In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.

On 16 February 2025, Samsung Bioepis announced that the European Commission has approved Obodence™ (60mg pre-filled syringe) and Xbryk™ (120mg vial), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.  The biosimilars are approved for the same indications as the reference medicines.

This announcement came just days after the FDA approval of Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb) on 13 February 2025.

Obodence™ and Xbryk™ received positive CHMP opinions in November 2024, and are the second set of denosumab biosimilars to be approved in the EU, following Sandoz’s Wyost® and Jubbonti® (approved May 2024).

The European Medicines Agency has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).  The CHMP adopted positive opinions for Celltrion’s Osenvelt®/CT-P41 and Stoboclo®/CT-P41 in December 2024.

On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis.

According to Galderma, Nemluvio® is the first approved mAb specifically targeting IL-31 receptor alpha, inhibiting the signalling of IL-31 (which drives itch and is involved in inflammation and skin barrier dysfunction), and the only approved biologic for atopic dermatitis and prurigo nodularis with 4-week dosing intervals from the start of treatment.

Nemluvio® received a positive opinion from the EMA’s CHMP in December 2024.

On 14 February 2025, the FDA approved Sanofi-Aventis US’s Merilog™ (injection, 10 mL)/Merilog™ SoloStar (injection, 3 mL) (insulin-aspart-szjj), biosimilars to Novo Nordisk’s Novolog® (insulin aspart), for the improvement of glycaemic control in adults and paediatric patients with diabetes mellitus.

Merilog™/Merilog™ SoloStar are the first rapid-acting insulin biosimilars to be approved in the US.  There were two long-acting insulin biosimilar products (insulin glargine) approved in 2021, Biocon/Mylan’s Semglee® and Eli Lilly’s Rezvoglar® (reference product: Sanofi’s Lantus®).

On 13 February 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its subcutaneous formulation for Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for rheumatoid arthritis (RA).  In the same announcement, Celltrion also confirmed that its intravenous (IV) Aptozma™ in 80 mg/4ml formulation received approval.

According to Celltrion, this approval completes its Aptozma™ line up in Korea following approval of IV Aptozma™ in 200mg/10ml and 400mg/20ml formulations in December 2024.  The December approval marked the first tocilizumab biosimilar approved in Korea.

In January 2025, Aptozma™ became the third tocilizumab biosimilar approved in the US, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 13 February 2025, CSL announced that the European Commission has approved Andembry® (garadacimab) to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

This is the third approval for the anti-FXIIa mAb, following January 2025 approvals by Australia’s Therapeutic Goods Administration (TGA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).  Andembry® was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for funding on Australia’s Pharmaceutical Benefits Scheme (PBS) at its November 2024 meeting.

Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug (previously referred to as CSL312) accepted in December 2023.  According to CSL, Andembry® is also under review by regulatory agencies in Japan, Switzerland and Canada.

On 13 February 2025, the US FDA approved Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb, SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively.  The biosimilars are approved for the same indications as the reference medicines.

Ospomyv™ and Xbryk™ are the second denosumab biosimilars to be approved in the US, following the approval of Sandoz’s Wyost® and Jubbonti® in March 2024.

There are also a number of denosumab biosimilars in the wings, with the FDA having accepted applications for review, including for: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).  In December 2023, Celltrion filed an abbreviated Biologics Licence Application (aBLA) for its denosumab biosimilar, CT-P41.  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  That litigation remains pending, as do similar proceedings brought by Amgen against Fresenius Kabi (FKS518/commenced October 2024) and Accord/Intas (INTP23/commenced November 2024).  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).  Amgen also settled its US litigation against Celltrion in January 2025, permitting launch of Celltrion’s yet to be US-approved denosumab biosimilar from 1 June 2025.

Samsung Bioepis received a positive opinion from the European Medicine Agency’s CHMP in November 2024 for its denosumab biosimilars (to be marketed as Obodence™ and Xbryk™ in Europe).

On 12 February 2025, Qyuns Therapeutics Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorisation application and supplemental application for QX001S, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for use in Crohn’s disease.  The NMPA has previously approved QX001S for the treatment of moderate-to-severe plaque psoriasis in adults (October 2024) and for use in paediatric plaque psoriasis (December 2024).

Qyuns Therapeutics jointly conducted the R&D and clinical trials for QX001S with Zhongmei Huadong, with QX001S obtaining clinical trial approval in 2018, its Phase I clinical trial completing in 2020, and the Phase III clinical study completing in June 2023.

QX001S was the first ustekinumab biosimilar approved in China, followed closely by CSPC Pharmaceutical Group which announced in November 2024 that its biologic licence application for ustekinumab was accepted by the NMPA.

On 12 February 2025, Pfizer announced that the US FDA has approved Adcetris® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL).  Specific indications include treatment for patients with:

• diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS);
• DLBCL arising from indolent lymphoma; and
• high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.

The approval is based on data from the Phase 3 ECHELON-3 study, which demonstrated that patients with relapsed/refractory DLBCL who were treated with Adcetris® in combination with lenalidomide and rituximab achieved a statistically significant and clinically meaningful improvement in overall survival.

On 12 February 2025, UCB announced that two-year data from the BE HEARD trials for Bimzelx® (bimekizumab) demonstrated sustained disease control in patients with moderate to severe hidradenitis suppurativa (HS).

The data revealed that after two years of treatment with bimekizumab, 53.1% of patients achieved mild disease status, compared to 0.0% at baseline.  Additionally, 83.4% of patients remained flare-free, and 86.9% of those who responded to treatment at 48 weeks maintained their response.

UCB launched its high dose presentation of Bimzelx® in the US in January 2025.  Bimzelx® has received several FDA approvals for new indications in recent months, including for moderate to severe HS (November 2024), and for active psoriatic arthritis, active non-radiographic axial spondyloarthritis and active ankylosing spondylitis (September 2024).  In May 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider UCB’s application to PBS-list Bimzelx® for moderate to severe HS.

On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for patients with recurrent respiratory papillomatosis, ocular conditions, liver cancer and advanced ovarian cancer.

Pharmac has also awarded Vegzelma® “principal supply status”, meaning it will be the main funded brand of bevacizumab in the New Zealand public health system until at least 31 August 2028.  All patients with recurrent papillomatosis are required to transition to Celltrion’s bevacizumab product by 1 August 2025, but “any brand” of bevacizumab will continue to be funded in public hospitals for patients with ocular conditions.

In the same announcement, Pharmac also reported that greater funding will be directed to Roche’s Tecentriq® (atezolizumab) for use in combination with bevacizumab for patients with liver cancer.

On 11 February 2025, the Australian Therapeutic Goods Administration (TGA) approved Alovtech and Cipla’s Uteknix®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two formulations:

• 90 mg/1 mL solution for injection pre-filled syringe (422260); and
• 45 mg/0.5 mL solution for injection pre-filled syringe (422259).

Both formulations are indicated for:

• the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
• alone or in combination with methotrexate, for the treatment of signs and symptoms of active psoriatic arthritis in adult patients where response to previous non-biological DMARD therapy has been inadequate.

Uteknix® has not been approved for Crohn’s disease or ulcerative colitis, or patients under the age of 18 years.

Uteknix® is being commercialised by Cipla in Australia pursuant to a 2021 agreement with Alvotech in relation to its ustekinumab biosimilar, AVT04.

This approval makes Uteknix® the fifth ustekinumab biosimilar approved in Australia, following Samsung Bioepis’ Epyztek® (October 2024), Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Ajemnye® (May 2024) and Wezlana® (January 2024).

Stelara® remains the only PBS-listed ustekinumab product at this stage, but that can be expected to change in the near future.  Amgen’s Wezlana® was recommended for listing at the March 2024 PBAC meeting, but has not yet been added to the PBS.  Celltrion’s SteQeyma® was recommended for PBS-listing at PBAC’s November 2024 meeting, while Samsung Bioepis’ Epyztek® will be considered at PBAC’s March 2025 meeting.

On 11 February 2025, MSD announced that Health Canada has approved Keytruda® (pembrolizumab) for the treatment of adults with resectable Stage II, IIIA, or IIIB non-small cell lung carcinoma (NSCLC), in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.

Keytruda® has been approved for the same indication in Europe (March 2024) and the US (October 2023), based on data from the Phase 3 KEYNOTE-671 trial.

Keytruda® was first approved in Canada in 2015 and has numerous cancer indications (alone or in combination therapy) including melanoma, bladder cancer, gastric cancer, and adenocarcinoma.

On 11 February 2025, Regeneron announced that the US FDA has accepted for review its resubmitted Biologics Licence Application (BLA) for linvoseltamab.  Linvoseltamab, a BCMAxCD3 bispecific antibody, is indicated for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least four lines of therapy, or those who have received three prior lines of therapy and are refractory to the last line of therapy.  The FDA’s target action date is 10 July 2025.

According to Regeneron, the BLA was resubmitted following certain manufacturing (third party fill/finish) issues previously raised by the FDA and which have now been resolved.

Linvoseltamab is also under review in Europe, with Regeneron’s marketing authorisation application (MAA) having been accepted by the EMA in February 2024.

On 10 February 2025, Bio-Thera Solutions announced that it has entered an exclusive US commercialisation and licence agreement with Intas Pharmaceuticals for BAT2506 (golimumab), biosimilar to J&J’s Simponi® and Simponi Aria®.

Under the agreement, Intas Pharmaceuticals’ subsidiary Accord BioPharma will be responsible for commercialising the product in the US, while Bio-Thera will retain responsibility for development, manufacturing and supply of BAT2506.  Bio-Thera will receive an upfront payment of US$21 million and further development and commercial milestone payments of up to US$143.5 million.

In May 2024, Bio-Thera entered an exclusive agreement with STADA for the commercialisation of BAT2506 in Europe.  In June 2021, it announced the commencement of a Phase 3 trial of BAT2506 in psoriatic arthritis, which was completed in 2023.

In November 2024, Alvotech/Advanz Pharma’s European marketing authorisation application for AVT05 was the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.

On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39).  The trial evaluated the efficacy and safety of Padcev® (enfortumab vedotin-ejfv) in combination with MSD’s Keytruda® (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).  The results demonstrated a sustained overall survival and progression-free survival benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up.

The combination therapy was approved in China in January 2025 for adult patients with locally advanced or metastatic urothelial cancer.  It has received several other approvals over the past 12 months, including in the UK (October 2024) the EU (September 2024), Japan (September 2024), Canada (August 2024), and the US (December 2023).

On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting another.

AstraZeneca’s Imfinzi® (durvalumab) will be reimbursed for use in combination with chemotherapy for the treatment of adults with newly diagnosed extensive-stage small cell lung cancer.  This follows recommendation of the combination therapy by UK’s NICE in January 2025.  Regeneron and Sanofi’s Libtayo® (cemiplimab) has also been accepted for reimbursement by the SMC for the treatment of adults with recurrent or metastatic cervical cancer, where the cancer has progressed on or after chemotherapy.

AstraZeneca and MSD’s Lynparza® (olaparib) was accepted for the treatment of adults with BRCA1 or 2 mutated HER2-negative advanced breast cancer, who have already received appropriate treatments for their type of breast cancer.  In December 2024, AstraZeneca and MSD announced positive results for Lynparza® in the treatment of breast cancer, demonstrating a reduced risk of death by 28%.

However, the SMC did not recommend reimbursement of Eisai and Biogen’s Leqembi® (lecanemab) for treating early-stage Alzheimer’s disease in adults who carry one or no copies of a gene called ApoE4.  The committee cited uncertainties surrounding the drug’s clinical benefits and concerns about its cost-effectiveness, but has invited a resubmission addressing those uncertainties.

The rejection follows a similar decision by the UK’s NICE in August 2024, which found that the benefits of lecanemab were too small to warrant making the drug available on the NHS.  On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Leqembi® in November 2024 for early Alzheimer’s disease following safety information that has since become available.

On 10 February 2025, Bayer announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.2 mg/ml solution for injection) for nAMD and DME.

According to Bayer, Eylea™ 8 mg was the first anti-VEGF to receive a 5-month label in the EU, but positive three-year results from the open-label extension studies of the PULSAR (nAMD) and PHOTON (DME) trials support 6-month extended treatment intervals for “a substantial proportion of patients”.

Eylea™ 8 mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron.  Regeneron holds exclusive rights to Eylea® 2mg (aflibercept 2 mg) and Eylea HD® in the US, while Bayer has licensed the exclusive commercialisation rights to the products outside the US.

High dose Eylea™ for intravitreal injection is approved for nAMD and DME in the EU (January 2024), Japan (January 2024), the UK (January 2024) and Australia (June 2024).  Eylea HD® is approved for nAMD, DME and diabetic retinopathy in the US (August 2023).  High dose Eylea® pre-filled syringe (OcuClick) was approved in Australia (October 2024) and Europe (September 2024).

On 8 February 2025, Regeneron presented positive results from the Phase 3 QUASAR trial investigating Eylea HD® for the treatment of patients with macular oedema following retinal vein occlusion (RVO).

Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)), with Takeda’s Entyvio® (vedolizumab).

This follows Intas’ August 2024 CDSCO approval to conduct a Phase 3 clinical study of INTP53 in patients with moderate to severely active ulcerative colitis.

Intas is not the only company to have a vedolizumab biosimilar in development.  For example, in September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis.  In February 2024, Polpharma Biologics announced that its PB016 (vedolizumab) demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.

On 8 February 2025, at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting, Regeneron presented positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept, 8 mg injection, known as Eylea™ 8mg in the EU and Japan) for the treatment of patients with macular oedema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions.

According to Regeneron, the QUASAR trial met its primary endpoint at 36 weeks, with patients receiving EYLEA HD® dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA® 2mg every 4 weeks.

In October 2024, Regeneron announced positive three year results for EYLEA HD® from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular oedema (DME), which demonstrated that the vast majority of EYLEA HD® patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year and achieved longer treatment intervals.

High dose EYLEA® for intravitreal injection has previously been approved for nAMD and DME in Australia (June 2024), the EU (January 2024), Japan (January 2024), and the UK (January 2024).  EYLEA HD® was approved for nAMD, DME and diabetic retinopathy in the US (August 2023).  More recently, high dose EYLEA® pre-filled syringe (OcuClick) was approved in Australia (October 2024) and Europe (September 2024).

On 7 February 2025, the Australian Therapeutic Goods Administration (TGA) approved UCB’s Rystiggo® (rozanolixizumab) in 140mg/mL solution for injection, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

In March 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider UCB’s application to PBS-list Rystiggo® for the same indication.

On 31 January 2025, UCB announced that Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the self-administration of Rystiggo® via an infusion (syringe pump) or a new manual push syringe method, after training from a healthcare professional.  Rystiggo® was approved as an add-on to standard therapy for adults with AChR or MusK antibody-positive gMG by the European Commission in January 2024 and by the US FDA in June 2023.

On 6 February 2025, the US Judicial Panel on Multijurisdictional Litigation granted Amgen’s request to centralise its BPCIA litigation alleging that each of Samsung Bioepis, Fresenius Kabi and Accord Biopharma are infringing US patents covering Amgen’s Prolia® and Xgeva® (denosumab).  The Panel ruled that each of the lawsuits involve “common issues of fact and law” and should be transferred to the US District Court for the District of New Jersey.  This was because Amgen had previously commenced three denosumab actions in that jurisdiction and the New Jersey Judge hearing the matters was familiar with the issues.

Amgen commenced the proceedings against Samsung Bioepis in August 2024 (District of New Jersey), Fresenius Kabi in October 2024 (Northern District of Illinois) and Accord Biopharma in November 2024 (Eastern District of North Carolina) in respect of Biologics Licence Applications filed for denosumab biosimilars SB16, FKS518 and INTP23, respectively.

A dispute with Sandoz, commenced by Amgen in May 2023 in the US District Court for the District of New Jersey, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025 (or earlier in certain undisclosed circumstances).  On 24 January 2025, Amgen announced that it had settled its patent infringement litigation against Celltrion in the US District Court for the District of New Jersey, relating to Celltrion’s biosimilar denosumab CT-P41.  An injunction, granted by consent, preventing Celltrion from launching CT-P41 in the US expires on 1 June 2025, permitting US launch of Celltrion’s denosumab biosimilars from that date.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  No other denosumab biosimilars have been approved in the US to date, although a number of applicants have had applications accepted for review by the FDA, including: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).

On 6 February 2025, Shanghai Henlius announced that it has entered into a licence agreement with Dr. Reddy’s for HLX15, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab) and Darzalex Faspro® (daratumumab and hyaluronidase-fihi), used in treating multiple myeloma.  The agreement grants Dr Reddy’s exclusive commercialisation rights for HLX15, covering both subcutaneous and intravenous formulations, across 42 European countries and the United States.  Henlius is responsible for development, manufacturing and supply, and will receive up to US$131.6 million, including US$33 million upfront and additional milestone payments and royalties based on annual net sales of HLX15.

In June 2024, Henlius announced the completion of phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.

Worldwide annual net sales of Darzalex® (daratumumab) in 2024 totalled US$11.7 billion.

On 5 February 2025, Novo Nordisk released its financial results for 2024, reporting a 26% sales increase (at constant exchange rates (CER)) to DKK 128.3 billion.  Sales in Novo Nordisk’s diabetes care segment (including Ozempic® (semaglutide), Rybelsus® (oral semaglutide) and Victoza® (liraglutide)) increased by 20% (CER) with its global diabetes value market share at 33.7% (constant over the last year).  Meanwhile, Novo Nordisk’s obesity care product sales (Wegovy® (semaglutide) and Saxenda® (liraglutide)) grew by 57% at CER to DKK 65,146 million, with its volume market share being 70.4%.

Recent highlights are reported to include the approval of Awiqli® (insulin icodec) in Europe (May 2024), Japan (June 2024) and China (June 2024); US approval (January 2025) and positive EU opinion (December 2024) for an update of the Ozempic® label based on the FLOW kidney trial; submission of the SOUL cardiovascular outcomes trial and STRIDE functional outcomes trial (oral semaglutide) in the US and EU; US approval (March 2024) of Wegovy® to reduce the risk of major cardiovascular events and positive EU opinion (July 2024) to reflect a risk reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either overweight or obesity without diabetes; and a positive EU opinion for a Wegovy® label expansion for obesity-related HFpEF (November 2024).

Novo Nordisk predicts sales growth of 16-24% at CER for 2025.  This is expected to be driven mainly by volume growth of GLP-1 based treatments for obesity and diabetes care, but also takes into account competition and continued pricing pressure within those markets.

On 5 February 2025, Shanghai Henlius Biotech announced that Hetronifly® (serplulimab) was approved by the European Commission for use in combination with carboplatin and etoposide as a first line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).  Hetronifly® is the first and only anti-PD-1 mAb approved in the European Union for ES-SCLC.

Hetronifly® received a positive opinion from the European Medicine Agency’s CHMP for ES-SCLC in September 2024.  In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC.  Henlius previously launched serplulimab as HANSIZHUANG® in certain Asian countries, including China.

Henlius entered an agreement with Intas Pharmaceuticals in October 2023, under which Intas received exclusive rights to develop and commercialise serplulimab in over 50 countries across Europe and India.  Hetronifly® will be commercialised in Europe by Intas subsidiary Accord Healthcare.

On 5 February 2025, Formycon announced that its partner, Klinge Biopharma, has entered an exclusive licence agreement with Taiwan-based Lotus Pharmaceutical for the commercialisation of FYB203/Ahzantive®, biosimilar to Regeneron’s Eylea® (aflibercept) in the following Asia Pacific countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam and Hong Kong.  Under a separate agreement, Formycon will supply the biosimilar to Lotus.

FYB203/Ahzantive®/Baiama® was granted marketing approval by the European Commission in January 2025.  It was approved in the US in June 2024, where it is subject to a preliminary injunction granted in June 2024, and upheld at the end of January 2025, resulting from a patent infringement proceeding brought by Regeneron in November 2023.

According to Formycon, it is “closely aligning” with Lotus to prepare regulatory submissions for FYB203/Ahzantive® in APAC according to the local regulatory requirements.

On 4 February 2025, Cytiva subsidiary media supplier HyClone Laboratories filed a motion in the US District Court for the District of Utah, seeking to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA patent infringement litigation Amgen commenced against Fresenius Kabi in October 2024.  Cytiva’s HyClone is not a party to the BPCIA litigation, which relates to Fresenius’ FKS518, biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).

Amgen’s subpoena requests HyClone Laboratories to provide information that includes the full formulation of its off-the-shelf cell culture supplement, HyClone™ Cell Boost™ 7a (CB7A).  Amgen alleges that Fresenius’ process for producing FKS518 uses CB7A and that the resulting cell culture medium infringes claims of Amgen’s patents (eg. US 10,167,492).

HyClone argues that the subpoena should be quashed for a number of reasons, including that the information sought is irrelevant and the request is overly burdensome because it would require the disclosure of trade secrets.

The litigation against Fresenius is one of five US proceedings commenced by Amgen in relation to denosumab biosimilars.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May, 2025 (or earlier in certain undisclosed circumstances).  Amgen also settled its litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025.  The remaining court proceedings, against Fresenius, Samsung Bioepis (SB16/commenced August 2024) and Accord/Intas (INTP23/commenced November 2024), remain pending.

On 4 February 2025, Genentech (a member of the Roche group) announced that the US FDA approved a new indication for Susvimo® (ranibizumab, 100mg/ml injection).  Susvimo® is the first and only approved continuous delivery treatment for diabetic macular oedema (DME), the leading cause of diabetes-related blindness.  Susvimo® is a refillable ocular implant containing a specialised formulation of ranibizumab.

The FDA’s approval was based on positive one-year results from the Phase 3 Pagoda study, a multicentre, randomised, active treatment-controlled, non-inferiority US-based Phase 3 study.  This study evaluated the efficacy, safety and pharmacokinetics of Susvimo® 100 mg/mL refilled every 6 months compared with monthly ranibizumab 0.5 mg intravitreal injections.

The approval follows the FDA’s acceptance of the supplemental BLA for Susvimo® in DME and diabetic retinopathy in July 2024.

The FDA had first approved Susvimo® in October 2021.  However, in October 2022, Genentech launched a voluntary recall after test results showed some implants did not perform to Genentech’s standards.  Genentech has since updated the Susvimo® implant and refill needle.  DME is the second indication approved for Susvimo®, after the FDA approved its relaunch for nAMD in July 2024.

On 3 February 2025, Johnson & Johnson (J&J) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an indication extension for its subcutaneous Rybrevant® (amivantamab):

• in combination with Lazcluze® (lazertinib) for the first-line treatment of certain adult patients with advanced non-small cell lung cancer (NSCLC); and
• as monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

Intravenous Rybrevant® has previously been approved in Europe for both of these indications (December 2024).

In December 2024, J&J announced that FDA issued a Complete Response Letter (CRL) for its US Biologics Licence Application (BLA) for a fixed subcutaneous combination of Rybrevant® and recombinant human hyaluronidase for NSCLC with EGFR mutations.

Shanghai Henlius Biotech announced on 2 February 2025 that the US FDA has accepted its Biologics Licence Application (BLA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).

The US acceptance of Henlius’ BLA follows the December 2024 acceptance of its NDA for HLX11 by China’s Center for Drug Evaluation of the National Medical Products Administration.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

On 31 January 2025, Celltrion announced that the US FDA has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in both subcutaneous and intravenous formulations for several indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and coronavirus disease 2019 (COVID-19).

The approval follows those for Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) and Fresenius Kabi’s Tyenne® (tocilizumab-aazg), both in September 2023.  Tyenne® was launched in the US in an IV formulation in April 2024 and in a subcutaneous formulation in July 2024.

Celltrion’s Aptozma™ was the first tocilizumab biosimilar to be approved in Korea in December 2024.  The biosimilar, marketed as Avtozma® in the EU, received a positive recommendation by the EMA’s CHMP in December 2024.

On 31 January 2025, Sanofi announced that China’s National Medical Products Administration (NMPA) has approved Sanofi’s Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT), based on data from the IMROZ phase 3 study.

Days earlier, on 28 January 2025, Pharmiweb reported that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also approved Sarclisa® for the same combination therapy and indication.

This follows approval of the isatuximab combo by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) one week earlier.  The combination therapy was also approved in the US in September 2024.

In November 2024, Sanofi succeeded in an appeal in the UK against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM).

On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.

Abbvie’s Humira® (adalimumab) received a number of recommendations, including:

• new PBS listings for enthesitis/spondylitis related JIA and chronic plaque psoriasis for paediatric patients; and
• amended PBS listings for moderate to severe ulcerative colitis and severe Crohn’s disease to allow dose escalation and more flexible dosing.

This follows PBS-listing of Sandoz’s high concentration adalimumab biosimilar, Hyrimoz®, in January 2025.

BMS’ PBS submission for Opdivo® (nivolumab) for the perioperative treatment of patients with resectable non-small cell lung cancer (NSCLC) was not recommended.  BMS has requested a post-PBAC meeting to look for a pathway to achieve PBS-listing for this indication.

Opdivo® is currently under review by Australia’s Therapeutic Goods Administration (TGA) for the treatment of advanced hepatocellular carcinoma or hepatocellular carcinoma that cannot be removed surgically.

On 30 January 2025, Judge Hacon of the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) is valid and infringed by Celltrion.

The decision was delivered in a proceeding commenced by Celltrion at the end of July 2023, seeking to revoke the patent on grounds including lack of novelty, lack of inventive step and insufficiency.  In September 2023, Genentech/Novartis filed a counterclaim for infringement.  Celltrion admitted that it infringed the patent if it was held to be valid.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was approved in the UK in July 2024.  It has also received approval in Europe (May 2024),  South Korea (June 2024), Australia (November 2024) and Canada (December 2024).  Celltrion submitted an aBLA in the US for Omlyclo® in March 2024.

The UK Court judgment follows a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent.  This was based on a lack of any “concrete indications” of any “imminent infringement” of the patent by Celltrion.  Although Celltrion had obtained European marketing authorisation for Omlyclo®, the Court found there was insufficient evidence of any specific timeline for price negotiations or that reimbursement applications had been made.  There was also no evidence of any samples actually being provided to potential customers.  In these circumstances, Novartis/Genentech’s application for provisional measures was refused.

Disputes between Novartis/Genentech and Celltrion regarding omalizumab are also ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague) and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023.  In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid.  The oral proceedings in the opposition are due to take place in April 2025.

On 30 January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection, indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.  The approval is subject to AbbVie providing further clinical data by 21 December 2026, unless otherwise agreed with Medsafe.

This news follows provisional approval of the same formulation and indications by Australia’s Therapeutic Goods Administration (TGA) in early January 2025.

At its January 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for four new medicines and expanded indications for eight.

The new medicines include AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) for patients with unresectable or metastatic hormone receptor (HR)-positive, HER2- negative breast cancer who have received endocrine therapy and at least an additional line of chemotherapy in the advanced setting.  Datroway® was approved in the US for the same indication in mid-January 2025 and in Japan in December 2024.  However, in December 2024, AZ/Daiichi voluntarily withdrew their European marketing authorisation application for the NSCLC indication of Datroway® based on CHMP feedback.  Daiichi Sankyo and AstraZeneca are jointly developing and commercialising the product pursuant to an agreement entered in July 2020, with Daiichi being the sponsor in Europe.

Pfizer’s Tivdak® (tisotumab vedotin) also received a positive opinion at the January CHMP meeting for treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.

The eight CHMP-recommended indication expansions included those for AZ’s Imfinzi® (durvalumab), for treatment as monotherapy of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy; BMS’ Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma; and Roche’s Ronapreve® (casirivimab/imdevimab) for COVID-19 in children.

Three biosimilars received positive opinions from CHMP at the January meeting as reported here.

On 30 January 2025, Amgen’s Pavblu® and Skojoy®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).  The two biosimilars are indicated for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).

Amgen’s Pavblu® was the first aflibercept biosimilar to be launched in the US in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.

There are four aflibercept biosimilars already approved (but not yet launched) in the EU: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama®/Ahzantive® (January 2025).  Celltrion’s Eydenzelt®/CT-P42 (aflibercept) received a positive opinion at the CHMP’s December 2024 meeting, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.

At its January 2025 meeting, the CHMP also provided good news for CuraTeQ, adopting a positive opinion for its Dyrupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) for the treatment of neutropenia.  This comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

On 29 January 2025, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Hympavzi™ (marstacimab) in 150mg/mL solution for injection, prefilled pen, indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with: severe haemophilia A without factor VIII inhibitors, or severe haemophilia B without factor IX inhibitors.

Hympavzi™ was approved in the EU and US for the same indication in November 2024 and October 2024, respectively.

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn preliminary injunctions preventing Samsung Bioepis and Formycon from launching their biosimilars to Regeneron’s Eylea® (aflibercept) in the US without a licence from Regeneron.

In both cases, the Appeals Court affirmed the earlier decisions of the US District Court for the Northern District of West Virginia (dated 14 June 2024 for Samsung Bioepis, and 21 June 2024 for Formycon), finding that Samsung Bioepis and Formycon each infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.  It is not known whether the decisions will be appealed to the US Supreme Court.

The BPCIA proceedings were initially commenced by Regeneron against Samsung Bioepis in November and December 2023, and against Formycon in November 2023.  Samsung Bioepis’ aflibercept biosimilar Opuviz™/SB15 received US approval in May 2024, while Formycon’s Ahzantive®/FYB203 was approved June 2024.