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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Celltrion Ph 1 Results for Secukinumab Biosimilar

Sep 10, 2025

On 10 September 2025, Celltrion announced that it will present its global Phase 1 clinical trial results for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), at the upcoming 2025 European Academy of Dermatology and Venereology Congress (EADV) to be held 17-20 September 2025.

A global phase 3 trial for Celltrion’s CT-P55 in patients with plaque psoriasis was approved by the FDA in August 2024.

Secukinumab biosimilars are also under development by Bio-Thera (phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024; phase 1 trial completed in 2023), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

Celltrion Set for 2025 EU Launch of Biosimilar Omalizumab

Sep 10, 2025

On 10 September 2025, Celltrion confirmed that it is planning the European launch of Omlyclo® (CT-P39), biosimilar to Genentech’s Xolair® (omalizumab), later this year to secure ‘first mover’ advantage.

Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025). The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

Aurobindo, Teva, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development. On 5 August 2025, Kashiv BioSciences and MS Pharma announced that they entered into a licence and supply agreement for Kashiv’s biosimilar omalizumab, ADL-018, for the Middle East and North Africa (MENA). Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Regeneron Files UK Patent Proceedings Against Alvotech and Fisher Clinical Services for Aflibercept Biosimilar

Sep 10, 2025

On 10 September 2025, Regeneron filed a patent infringement suit against Alvotech and Fisher Clinical Services UK Limited in the High Court of Justice for England & Wales. The details of the allegations are not yet publicly available, but the dispute is reported to relate to Alvotech’s aflibercept biosimilar, Mynzepli® (AVT06), biosimilar to Regeneron/Bayer’s Eylea®.

Alvotech partnered with Advanz Pharma for the commercialisation of Mynzepli® into the UK and Europe. Under the June 2024 agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive. Mynzepli® was approved by the European Commission in August 2025 across all Eylea® indications, in pre-filled syringe and vial presentations, following a positive CHMP opinion in June 2025.

Fisher Clinical Services UK appears to be an end-to-end global clinical supply chain and logistics company based in the United Kingdom.

The UK lawsuit against Alvotech/Fisher was filed a day after Sandoz settled its US aflibercept litigation with Regeneron. Regeneron remains in US BPCIA litigation against each of Amgen (Pavblu™), Samsung Bioepis (2 actions; Opuviz™/SB15), Formycon (Ahzantive®/FYB203) and Celltrion (2 actions, CT-P42) regarding aflibercept biosimilars. Preliminary injunctions were granted preventing US 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).

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.

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).

On 3 September 2025, the Federal Court of Australia refused to award Regeneron/Bayer an interlocutory injunction preventing Sandoz from launching its aflibercept biosimilar in Australia.

Sandoz’s Biosimilar Aflibercept US Launch Set for Q4 2026 Following Regeneron Settlement

Sep 9, 2025

On 9 September 2025, Sandoz announced that it has settled all US patent disputes with Regeneron relating to Sandoz’s Enzeevu®, biosimilar to Regeneron’s Eylea® (aflibercept). Under the settlement, Sandoz is permitted to launch its biosimilar aflibercept in Q4 2026, or earlier in certain undisclosed circumstances.

Regeneron commenced BPCIA litigation against Sandoz in the US District Court for the District of New Jersey on 26 August 2024, asserting infringement of 46 US patents relating to aflibercept. The Court filing came two weeks after the FDA approved Sandoz’s Enzeevu® (aflibercept-abzv) for treatment of nAMD.

The Sandoz US proceeding was one of many Regeneron US proceedings regarding aflibercept biosimilars.

Biocon and Regeneron settled US aflibercept BPCIA litigation 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. Litigation remains pending against Amgen (Pavblu™), Samsung Bioepis (2 actions; Opuviz™/SB15), Formycon (Ahzantive®/FYB203) and Celltrion (2 actions, CT-P42).
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).

The only biosimilar aflibercept currently on the market 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).

Regeneron Aflibercept PI Refused Against Sandoz, AU Market Open to Biosimilars

Sep 8, 2025

On 8 September 2025, Justice Rofe of the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).

Regeneron and Bayer commenced proceedings against Sandoz on 4 June 2025 alleging infringement of Regeneron’s patent no. AU2012205599 relating to methods of treatment for angiogenic eye disorders. Regeneron/Bayer sought both an interlocutory injunction and final relief, and Sandoz cross-claimed for invalidity of the patent.

The interlocutory injunction application was heard on 14 August 2025 with Justice Rofe announcing her decision on 3 September 2025 and publishing her reasons for judgment on 8 September 2025. Justice Rofe found an “insufficient likelihood of success” that Regeneron/Bayer’s infringement case would succeed at a final hearing and that the balance of convenience did not favour the grant of the interlocutory injunction.

Sandoz’s aflibercept biosimilars, 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, with PBS listing to commence from 1 December 2025. Sandoz indicated during the court proceeding that while Afqlir® will be launched in Australia in the coming months, it does not intend to launch Enzeevu® in 2025.

Subject to any settlement, the case will now proceed to a hearing for final relief.

Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, has filed legal proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter scheduled for 8 October 2025.

Regeneron/Bayer are separately seeking preliminary discovery from Sandoz in relation to a second Regeneron’s aflibercept patent, AU2020397865, which is scheduled for hearing on 6 November 2025. Regeneron/Bayer have indicated that they may wish to seek an interlocutory injunction in relation to that patent, depending on the outcome of the preliminary discovery application.

On 9 September 2025, Sandoz announced that it settled all US patent disputes between it and Regeneron relating to Sandoz’s Enzeevu®. Under the terms of the US settlement, Sandoz is permitted to launch its biosimilar aflibercept in the US in Q4 2026, or earlier in certain undisclosed circumstances.

Pembrolizumab Included on WHO Essential Medicines List

Sep 5, 2025

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.

Samsung Bioepis & Amgen Settle BPCIA Denosumab Litigation

Sep 5, 2025

On 5 September 2025, consent orders were made by the US District Court for the District of New Jersey recording that Samsung Bioepis and Amgen have entered into a settlement agreement resolving pending BPCIA patent litigation in relation to denosumab. The terms of the settlement agreement are confidential and the launch date for Samsung Bioepis’ denosumab biosimilars is unknown.

The litigation had been commenced by Amgen on 12 August 2024 against Samsung Bioepis and Samsung Biologics asserting infringement of 36 patents relating to denosumab. The lawsuit followed the filing by Samsung Bioepis of an aBLA with the FDA for its biosimilars (SB16) to Amgen’s Prolia® and Xgeva®. Samsung Bioepis’ biosimilars were approved in the US in February 2025 as Ospomyv™ and Xbryk™.

Amgen has now entered into five US denosumab litigation settlements. 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. Accord and Intas settled with Amgen in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025.

Amgen still has pending US denosumab litigation against Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon.

Celltrion/Arrotex’s Ustekinumab and Omalizumab Biosimilars Launched in Australia

Sep 4, 2025

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).

Counterfeit Opdivo® (Nivolumab) Seized in Brazil

Sep 4, 2025

On 4 September 2025, Brazil’s National Health Surveillance Agency (Anvisa) announced that it seized a batch of a drug sold under the name Opdivo®, after medicine registration owner Bristrol-Myers Squibb notified Anvisa that the batch was not known to be genuine.

Counterfeit Opdivo® has previously been reported in the USA, resulting in a United States federal grand jury indicting a person from India for allegedly selling the counterfeit cancer drugs and shipping them to Houston.

As previously reported in the context of counterfeit supply of Novo Nordisk’s semaglutide products Ozempic® and Wegovy® in the US, counterfeit drugs are often combated by civil lawsuits. When a counterfeit product contains no active ingredient, patent protection is unlikely to apply and any civil suit would need to rely instead on trade mark rights, fair trading laws and other related law applicable in the relevant jurisdiction. It is not known whether any manufacturer will file a civil suit in relation to this case.

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.

Polpharma Inks Licensing Deal with MS Pharma for Guselkumab, Ocrelizumab and Vedolizumab Biosimilars

Sep 2, 2025

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.

Pearce IP BioBlast® for the week ending 29 August 2025

Sep 2, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 29 August 2025 are set out below:

Aflibercept

28 August 2025 | KR | Bayer’s Eylea® 8mg PFS (OcuClick) Approved in Korea

Bevacizumab

28 August 2025 | US | FDA Issues Second Complete Response Letter to Outlook Therapeutics for Ophthalmic Bevacizumab

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™… Read more here.

Daratumumab

22 August 2025 | RU | BIOCAD Obtains Approval of First Daratumumab Biosimilar

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… Read more here.

Denosumab

1 September 2025 | AU | Amgen’s Supplemental Denosumab Brands PBS-Listed following Sandoz Biosimilar Launch

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… Read more here.

26 August 2025 | TH | Abbott’s Denosumab Biosimilar First to be Approved in Thailand

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

Guselkumab

28 August 2025 | UK | UK’s NICE Recommends Janssen’s Guselkumab for Crohn’s and UC Within NHS

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… Read more here.

Nivolumab, Ipilimumab

25 August 2025 | JP | New Indication Alert: Opdivo®/Yervoy® Combo Approved in Japan for MSI-High CRC

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… Read more here.

Trastuzumab

26 August 2025 | UK | CuraTeQ’s Trastuzumab Biosimilar UK Approved

Trastuzumab, Infliximab

28 August 2025 | VN | Celltrion Launches Trastuzumab and Infliximab Biosimilars in Vietnam

On 28 August 2025, Celltrion announced that it has launched two biosimilars in Vietnam… Read more here.

Ustekinumab

26 August 2025 | EU | Bio-Thera/Richter’s Biosimilar Ustekinumab EU Approved

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… Read more here.

12 August 2025 | CH | Samsung Bioepis Invalidates Janssen Ustekinumab Patent in Switzerland

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… Read more here.

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Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

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Lawyer

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FDA Approves Shanghai Henlius/Organon’s Denosumab Biosimilars

Sep 2, 2025

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.

CapVest to Acquire Majority Stake in STADA

Sep 1, 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 biosimilar 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), and 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.

Mabwell/Searl’s Denosumab Biosimilar Approved in Pakistan

Sep 1, 2025

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 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.

EU Approves Ph 3 Trial for Celltrion’s Daratumumab Biosimilar

Sep 1, 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®.

Amgen’s Supplemental Denosumab Brands PBS-Listed following Sandoz Biosimilar Launch

Sep 1, 2025

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.

India’s CDSCO Approves Lupin’s Ph 1 Trial for Biosimilar Peg Certolizumab

Sep 1, 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.

Celltrion Launches Trastuzumab and Infliximab Biosimilars in Vietnam

Aug 28, 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).

UK’s NICE Recommends Janssen’s Guselkumab for Crohn’s and UC Within NHS

Aug 28, 2025

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.

FDA Issues Second Complete Response Letter to Outlook Therapeutics for Ophthalmic Bevacizumab

Aug 28, 2025

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.

Bayer’s Eylea® 8mg PFS (OcuClick) Approved in Korea

Aug 28, 2025

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.

Pearce IP BioBlast® for the fortnight ending 22 August 2025

Aug 26, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the fortnight ending 22 August 2025 are set out below:

Aflibercept

21 August 2025 | EU | Alvotech/Advanz’s Biosimilar Aflibercept EU Approved

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-… Read more here.

20 August 2025 | EU | Sam Chun Dang’s Biosimilar Aflibercept Approved in EU

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… Read more here.

20 August 2025 | US | FDA Extends Review Period for Two of Regeneron’s Eylea HD® Submissions

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… Read more here.

Aflibercept, Etanercept, Infliximab

22 August 2025 | AU | Australia’s PBAC Recommends Reimbursement of Sandoz, Biocon and Celltrion Biosimilars to Aflibercept, Etanercept and Infliximab (Respectively)

On 22 August 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) July 2025 meeting were published, including recommendations for the listing of three biosimilars on… Read more here.

Bevacizumab

21 August 2025 | ID | PK | CO | BioDlink’s Biosimilar Bevacizumab Approved in Indonesia, Pakistan and Columbia

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)… Read more here.

13 August 2025 | CN | Shanghai Henlius & EssexBio’s Ophthalmic Bevacizumab Biosimilar Application Accepted in China

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… Read more here.

Dupilumab

19 August 2025 | CN | CSPC’s Biosimilar Dupilumab PRC Clinical Trials Approved

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… Read more here.

Infliximab

21 August 2025 | NZ | Pfizer’s IV Infliximab Biosimilar Approved in NZ

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… Read more here.

Nivolumab, Ipilimumab

19 August 2025 | CA | New Indication Alert: Opdivo® and Yervoy® Combination Approved in Canada for CRC and HCC

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… Read more here.

Ofatumumab

11 August 2025 | AU | Australia’s TGA Approves New Brand of Novartis’ Ofatumumab

On 11 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved a new brand of Novartis’ ofatumumab… Read more here.

Pembrolizumab

22 August 2025 | AU | PBAC Refuses MSD’s Proposal for Broad Keytruda® PBS Listing

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… Read more here.

14 August 2025 | PY | Bioéticos Claims Launch of First Pembrolizumab Biosimilar in Paraguay

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… Read more here.

Pertuzumab

14 August 2025 | US | Genentech and Roche Sue Shanghai Henlius and Organon to Block US Launch of Biosimilar Pertuzumab

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®… Read more here.

Ranibizumab

12 August 2025 | EU | APAC | Lupin Partners with Sandoz to Commercialise Ranibizumab Biosimilar in EU & APAC

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… Read more here.

Tocilizumab

25 August 2025 | EU | UK | CH | Bio-Thera & STADA Extend Partnership to Biosimilar Tocilizumab

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… Read more here.

Ustekinumab

18 August 2025 | US | Accord BioPharma Launches Biosimilar Ustekinumab in US

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… Read more here.

18 August 2025 | US | Teva Subsidiary to Launch Unbranded Ustekinumab Biosimilar in US via MedImpact

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… Read more here.

12 August 2025 | IT | Celltrion Wins Italian Steqeyma® Supply Contracts

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… Read more here.

About Pearce IP

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Chantal Savage

Special Counsel, Lawyer

Nathan Kan

Lawyer

Bio-Thera/Richter’s Biosimilar Ustekinumab EU Approved

Aug 26, 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).

CuraTeQ’s Trastuzumab Biosimilar UK Approved

Aug 26, 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).