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 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.