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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.

Samsung Bioepis Launches Biosimilar Aflibercept in Europe

May 31, 2026

On 31 May 2026, Samsung Bioepis announced that it has launched Opuviz™/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg, in Europe through direct sales.

The launch follows a settlement agreement between Samsung Bioepis and Regeneron/Bayer in relation to the aflibercept biosimilar announced in January 2026.  Under the agreement, Samsung Bioepis was permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement from May 2026 (excluding Korea where it had already been on the market as Afilivu® since 2024).  Samsung Bioepis has a separate settlement agreement with Regeneron/Bayer for North America, permitting launch of Opuviz™ in the US from January 2027.

Opuviz™ was the third aflibercept biosimilar to be approved in the EU in November 2024 and has been approved elsewhere, including the UK (April 2025), the US (May 2024), Korea (as Afilivu®) (February 2024) and Australia (September 2025).

The European launch of Opuviz™ comes two weeks after Formycon/Klinge launched their aflibercept biosimilar, FYB203, in key European markets.  Aflibercept biosimilars have also been launched in Europe including by Sandoz (Afqlir® launched in UK in November 2025) and Celltrion (Eydenzelt® launched in UK and EU in December 2025).  Settlement agreements between Regeneron/Bayer and other companies permit further 2026 EU biosimilar aflibercept launches, including for Alvotech and Biocon.

Pearce IP and 5 Leaders Ranked in IAM Patent 1000 2026 for AU and NZ Patent Prosecution and Litigation

May 29, 2026

Pearce IP and five of its leaders have been recognised in the IAM Patent 1000 for 2026, with rankings across Australia and New Zealand for patent litigation and patent prosecution.

2026 marks the sixth consecutive year of Pearce IP Australia being ranked in the IAM Patent 1000 – one of only 51 law firms recognised this year – and our second consecutive year achieving Silver rankings for both Prosecution and Litigation.

Pearce IP New Zealand has been ranked for Prosecution by IAM Patent 1000 every year since the office opened in New Zealand in 2024 and is one of only 17 firms listed this year.

In addition to Pearce IP’s firm-wide rankings, several of the firm’s key leaders received individual recognition, part of only 199 individuals listed in Australia and 53 in New Zealand:

Naomi Pearce | Founder & CEO, Executive Lawyer, Patent and Trade Mark Attorney
Gold (AU) Litigation; Gold (AU) Prosecution.

“…dual qualifications as an executive lawyer and patent attorney shape Pearce IP’s integrated approach to life sciences IP.  With a background in molecular biology and substantial experience in both private practice and in‑house environments, she is the strategic driver behind many of the firm’s most complex patent programmes.  Pearce’s practice spans early‑stage innovation capture, freedom‑to‑operate assessment, and sophisticated market‑entry strategy for advanced therapeutics, positioning her as the central architect of the firm’s cross‑border patent planning.” – IAM Patent 1000

Helen Macpherson | Executive Lawyer & Head of Litigation AU
Silver (AU) Litigation; Silver (AU) Transactions.

“…scientific grounding in biochemistry and molecular biology enables her to navigate disputes involving tight intersections of law and technical subject matter.  Her role within the team ensures continuity from early strategic advice through to the demands of active enforcement, amendments and validity analysis, creating a strong bridge between legal theory and courtroom execution.” – IAM Patent 1000

Paul Johns | Executive Lawyer, Trade Mark Attorney & Head of Litigation NZ
Recommended (NZ) Litigation.

“…brings more than 25 years of experience to the practice, having previously worked at large multinational firms, and combines strong technical and legal acumen in IP litigation with a scientific background in genetics and microbiology.” – IAM Patent 1000

Jacinta Flattery-O’Brien | Special Counsel, Patent Attorney
Silver (AU) Prosecution.

“With over 20 years’ experience and a doctorate in a biotech discipline, Flattery-O’Brien leads prosecution work for biotechnology, pharmaceutical and biopharmaceutical portfolios.  Her practised hand in drafting, claim development and multi‑jurisdictional coordination ensures that the firm’s strategic advice is matched by technically precise and commercially relevant protection.” – IAM Patent 1000

Chantal Savage | Special Counsel, Lawyer
Next Generation Leader (AU).

“Australian and UK experience adds further depth in multi‑jurisdictional patent disputes.  Savage’s work spans pharmaceuticals, biopharmaceuticals, gene‑editing, medical devices and a range of engineering‑based technologies.” – IAM Patent 1000

IAM 1000 comments:

“Pearce IP has established itself as a go‑to outfit for life sciences mandates across Australia and New Zealand.  Combining technical depth with seasoned legal insight, the firm delivers integrated prosecution and advisory services for innovators and companies operating in pharmaceuticals, biopharmaceuticals, biotechnology, ag‑tech, food‑tech and med‑tech.  Its practitioners bring substantial scientific grounding, enabling the group to navigate complex portfolios, product lifecycles and cross‑border patent strategies with ease.  The team is also recognised for its strong collaborative culture and for fielding one of the region’s most experienced concentrations of life sciences specialists.”

 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Shanghai Henlius’ Biosimilar Pertuzumab Approved in China

May 29, 2026

On 29 May 2026, Shanghai Henlius announced China’s National Medical Products Administration (NMPA) has approved its pertuzumab (HLX11/Hanbeiyou®, marketed as Poherdy® in the US and Europe), biosimilar to Roche’s Perjeta® (pertuzumab).  Hanbeiyou® is approved for all Perjeta® indications.

HLX11/Poherdy® was the first pertuzumab biosimilar approved in the US (November 2025) and EU (April 2026).  In the US, a BPCIA patent challenge by Genentech/Roche against Henlius/Organon regarding Poherdy® was settled in January 2026 on confidential terms, with no details of any planned US launch of Poherdy® being disclosed to date.

Organon has exclusive global commercialisation rights to HLX11, “except for China; including Hong Kong, Macau and Taiwan”, under a June 2022 deal.

Pertuzumab biosimilars have been approved in India, including Intas’ biosimilar (December 2024, subject to submission of further studies), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved.  Pertuzumab biosimilars are also under development by Sandoz and EirGenix.  In February 2026, Genentech commenced US ITC proceedings against Biocon regarding its pertuzumab biosimilar, BMAB 1500.

Replimune Makes Third Submission to FDA for Vusolimogene Oderparepvec Plus Nivolumab

May 29, 2026

On 29 May 2026, Replimune announced that, following collaborative communications with the FDA, the company and the FDA have aligned on a path for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.  Replimune says it will resubmit the RP1 BLA in the coming days.  The FDA has indicated it will treat the BLA resubmission as an urgent matter upon receipt and will prioritise its review in recognition of the significant unmet need for patients in the advanced melanoma community.

This announcement has caused some recovery in Replimune’s share price following the negative impact of the FDA’s April 2026 rejection of the first resubmission of the BLA, which in turn followed the rejection of the original November 2024 application.

Other reports record that Replimune met with the White House and that the FDA has been “pushed” to reexamine the RP1 BLA.

Celltrion Submits Korean Application for Biosimilar Trastuzumab SC

May 28, 2026

On 28 May 2026, The Seoul Economic Daily reported that Celltrion has filed an application with the Korean Ministry of Food and Drug Safety for approval of Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™).  The subcutaneous (SC) application was submitted for all Herceptin® SC indications, including the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

This follows Celltrion’s announcement on 30 April 2026 that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC.  The timing of these applications aligns with Celltrion’s December 2025 announcement that it had been conducting clinical trials for Herzuma® SC (CT-P6 SC) since February 2025 and planned to submit applications for approval of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.  According to Celltrion, it plans to proceed with regulatory submissions for Herzuma® SC in other major countries.

There are currently no biosimilar SC formulations of trastuzumab on the market and Celltrion considers it is well-placed to enjoy a “first mover” advantage.  In January 2026, Biocon Biologics announced that it had added a trastuzumab/hyaluronidase product, referencing Roche’s Herceptin® SC/Herceptin Hylecta™, to its biosimilar development pipeline.

FDA Approves Label Expansion for Tremfya® (Guselkumab) to Include Inhibition of Structural Joint Damage in Psoriatic Arthritis

May 28, 2026

On 28 May 2026, Johnson & Johnson (J&J) announced that the FDA has approved a supplemental Biologics License Application (sBLA) to update the Tremfya® (guselkumab) label to include data demonstrating that the treatment inhibits the progression of structural joint damage in adults with active psoriatic arthritis (PsA).  The label update positions Tremfya® as the only IL-23 inhibitor with demonstrated structural inhibition in its label, offering patients with active PsA a first-line treatment option that provides both symptom control and protection against irreversible joint damage.

Tremfya® was first approved in the US for moderate-to-severe plaque psoriasis (PsO) in July 2017.  Since then, its approved indications have been significantly expanded: the FDA approved Tremfya® for moderately to severely active ulcerative colitis (UC) in September 2024, followed by approval of a subcutaneous induction regimen for UC in September 2025, and approval for moderately to severely active Crohn’s disease in March 2025.  In September 2025, the FDA also extended Tremfya®’s PsO and PsA approvals to children aged six and older weighing at least 40 kg.

No guselkumab biosimilars have been approved in any major market, and biosimilar development of guselkumab appears to be at early stages globally.  In September 2025, Polpharma Biologics and MS Pharma entered into a licensing agreement for the commercialisation of PB019 (biosimilar guselkumab) in the Middle East and North Africa (MENA) region.  Alvotech has a proposed guselkumab biosimilar in development (partnered with Advanz Pharma for commercialisation in the EU, UK and Switzerland), and Samsung Bioepis announced in January 2026 that it has biosimilar guselkumab in development.

 

Pearce IP Ranked in 2027 ‘Best Law Firms Australia’ for Life Sciences & Intellectual Property

May 28, 2026

We are delighted to share that Pearce IP has been ranked in the 2027 edition of Best Law Firms – Australia in the categories of Life Sciences and Intellectual Property.

Published by Best Lawyers and underpinned by a rigorous methodology, the Best Law Firms – Australia is in its third edition.  This is the second time Pearce IP has been recognised, with rankings in both Life Sciences and IP.

With the Sydney region category spanning a broad footprint – from the Sydney CBD and Greater Sydney through to the Hunter region, Southern Highlands, Central West NSW, and the Illawarra – these rankings recognise excellence across one of Australia’s most commercially significant and highly competitive legal markets.

Being ranked among the top 3% of law firms nationally is a significant achievement and reflects our consistent focus on excellence, as well as our commitment to delivering meaningful results for our clients.

Naomi Pearce, founder and CEO of Pearce IP says:

“I never cease to be impressed by the calibre and commitment of the Pearce IP team. It is both a pleasure and a privilege to see the firm again recognised for its legal/IP sophistication and industry specialisation. This achievement reflects the strength of our independent, values-driven approach and our unwavering focus on delivering exceptional outcomes for our clients.”

Earlier this year, Helen Macpherson was also recognised in Best Lawyers Australia 2027 for Intellectual Property Law and Life Sciences, continuing her unbroken run of listings every year since 2017.

 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Italy’s Competition Regulator Investigates Biogen’s Alleged Anti-Competitive Conduct in MS Market Due to Stratify Natalizumab Test

May 27, 2026

On 27 May 2026, Fierce Pharma reported that Italy’s competition regulator (AGCM) has commenced an investigation into Biogen’s alleged abuse of its dominant position in the multiple sclerosis drug market.

Biogen markets Tysabri® (natalizumab) for the treatment of multiple sclerosis.  Treatment with natalizumab can cause a rare but serious side effect, which means that patients are required to undergo a specific test (the ‘anti-JCV test’) before and during treatment with natalizumab.  AGCM is concerned that Biogen is using its anti-JCV Stratify test to exclude or limit competition from Sandoz by tying the use of the test to the purchase of Tysabri®, and refusing to make it commercially available to patients treated with Sandoz’s natalizumab product, Tyruko®.

Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019.  As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.  Tyruko® is approved in multiple markets, including the US (August 2023), Europe (September 2023) and Australia (April 2025).

Pearce IP BioBlast® for the week ending 22 May 2026

May 26, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 22 May 2026 are set out below:

Aflibercept

On 19 May 2026, Formycon and Klinge Biopharma announced that the European launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), commenced… Read more here.

Denosumab

On 21 May 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) approved an expanded set of indications for Maiweijian™, biosimilar to… Read more here.

Pembrolizumab

On 20 May 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved MSD’s Keytruda SC™ (pembrolizumab and… Read more here.

Ranibizumab, Liraglutide

On 22 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its May 2026 meeting, including… Read more here.

Semaglutide

On 20 May 2026, The Economics Times reported that Zydus Lifesciences plans to commercialise its generic semaglutide formulation across more than 20 markets over the… Read more here.
On 22 and 23 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two new formulations of… Read more here.

Ustekinumab

On 20 May 2026, Samsung Bioepis announced that it has launched SB17, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan through its local marketing partner… Read more here.
 

Biopharma Deals

On 22 May 2026, Polpharma Biologics and Tuteur announced that they have entered into an exclusive licensing agreement for the commercialisation of an unnamed biosimilar… Read more here.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

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

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. 

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Chantal Savage

Chantal Savage

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.

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.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Boan Biotech Files US BLAs for Denosumab Biosimilars and Receives Approval for New Indication in China

May 26, 2026

On 29 May 2026, Boan Biotech announced that it has submitted Biologics License Applications (BLAs) to the FDA for two denosumab biosimilars: BA6101 (denosumab 60 mg) and BA1102 (denosumab 120 mg), biosimilars to Amgen’s Prolia® and Xgeva® respectively.  The BLAs seek approval for all indications of the reference products.

Days earlier, on 26 May 2026, Boan Biotech announced that China’s National Medical Products Administration (NMPA) approved its supplemental application for Boluojia® (BA11021) (denosumab injection 120 mg), biosimilar to Xgeva®, for the treatment of patients with bone metastases from solid tumours or multiple myeloma, to delay or reduce the risk of skeletal-related events (SREs), which include pathological fractures, spinal cord compression, and bone-directed radiation or surgery.  Boluojia® was first approved in China in May 2024 for the treatment of giant cell tumour of bone.

Boan Biotech’s Boyoubei® (BA6101) was approved in China in November 2022 and in Bolivia in January 2026.  In November 2025, Boan Biologics’ MAAs for BA6101 and BA1102 were accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA).  According to Boan Biotech, regulatory submissions for its denosumab biosimilars are also planned for Europe and Japan, among other regions.

Denosumab biosimilars have been approved and launched around the world by a variety of sponsors.  In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ included on US formularies from 1 April 2026), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched January 2026), Accord’s Osvyrti® and Jubereq® (approved November 2025) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

First Patient Dosed in Phase I Trial for Shanghai Henlius’ Biosimilar Daratumumab SC

May 26, 2026

On 26 May 2026, Shanghai Henlius announced that the first patient has been dosed in its phase 1 international multicentre clinical trial of HLX15-SC (daratumumab and hyaluronidase-fihj), biosimilar to J&J’s Darzalex Faspro®, for the treatment of multiple myeloma.

Shanghai Henlius’ Investigational New Drug (IND) application for the phase 1 clinical trial of HLX15-SC was approved by the FDA in February 2026, shortly after the trial was approved in China.

Henlius is also developing an IV form of HLX15, having completed a successful Phase 1 clinical trial of HLX15-IV against US, EU and CN sourced Darzalex® (daratumumab) in June 2024.

Both SC and IV forms of HLX15 will be commercialised by Dr Reddy’s in Europe and the US under the terms of a licence agreement announced in February 2025.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025 for Daratumia®.  Daratumumab biosimilars are under development, including by CSPC Pharmaceutical Group, which obtained approval from the NMPA in December 2025 to conduct clinical trials in China of its Daratumumab Injection, and Celltrion, whose Phase 3 clinical trial plan for CT-P44 (daratumumab) was approved in Europe in September 2025.

Outlook Therapeutics Wins Appeal of FDA’s CRL for Ophthalmic Bevacizumab, Plans to Resubmit BLA in June 2026

May 26, 2026

On 26 May 2026, Outlook Therapeutics announced that the FDA has granted an appeal following the completion of a Formal Dispute Resolution (FDR) process for ONS-5010/Lytenava™ (bevacizumab-vikg) for wet AMD.  The FDR process is an appeal mechanism that permits a sponsor to obtain formal review of any FDA decision by raising the matter with the supervisor of the employee who made the decision.

In December 2025, the FDA issued a Complete Response Letter (CRL) for the second resubmission of ONS-5010/Lytenava™, recommending that additional confirmatory evidence be provided to support Outlook’s application, though it did not clarify what type of evidence would be acceptable.  Outlook subsequently attended a Type A meeting with the FDA in March 2026 to discuss the CRL and then submitted its Formal Dispute Resolution Request in April 2026.

In its appeal decision, the FDA concluded that substantial evidence of effectiveness has been established for Lytenava™ for the treatment of wet AMD, despite the earlier CRL.  The decision directs the FDA’s Division of Ophthalmology (Division) and Office of Specialty Medicine (OSM) to work with Outlook Therapeutics to reach agreement on final labelling.

Outlook Therapeutics expects to resubmit the BLA for ONS-5010/Lytenava™ in June 2026.  If approved, ONS-5010/Lytenava™ would be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA.

Lytenava™ was approved in the EU in May 2024 and in the UK in July 2024.  It was launched in the UK and Germany in June 2025.

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.

Amneal & Kashiv Challenge US Omalizumab Patent

May 26, 2026

On 26 May 2026, Amneal Pharmaceuticals and Kashiv Biosciences filed a petition with the Patent Trial and Appeal Board for inter partes review of Genentech/Novartis’ US Patent No. 12,030,959.  The patent relates to methods for treating food allergies in paediatric patients by administering omalizumab.

Amneal and Kashiv argue that the claims of the US959 patent are invalid because they lack novelty and/or are obvious, including in light of articles disclosing the results of phase 1 or 2 clinical trials of omalizumab in patients with food allergies.

Amneal submitted a Biologics Licence Application (BLA) to the FDA for its omalizumab (ADL-018), biosimilar to Genentech/Novartis’ Xolair®, in September 2025.  ADL-018 was developed by Kashiv, with Amneal holding exclusive US commercialisation rights for the product, under a July 2024 licensing agreement.

Kashiv has also entered into agreements for the commercialisation of ADL-018 in other regions, including with CRISTÁLIA for LATAM markets (August 2025), MS Pharma for MENA markets (August 2025) and 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.

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world.  Omlyclo® was approved in the US in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and in December 2025  (300mg formulation).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Omalizumab biosimilars are in development, including by Teva (acceptance of regulatory applications for review by the FDA and EMA announced March 2026) and CuraTeQ (phase 3 biosimilar omalizumab trial completed April 2026).

Polpharma Biologics Inks Exclusive Licensing Deal with Tuteur for Autoimmune Disease Biosimilar in LATAM

May 22, 2026

On 22 May 2026, Polpharma Biologics and Tuteur announced that they have entered into an exclusive licensing agreement for the commercialisation of an unnamed biosimilar for the treatment of an autoimmune disease in Latin America, excluding Brazil.

Under the agreement, Swiss-based Polpharma Biologics will be responsible for the development, manufacture and supply of the product, while Argentina-based Tuteur will be responsible for the commercialisation, marketing and distribution across Latin America, excluding Brazil.

The unnamed biosimilar is currently in development, with the companies anticipating a regulatory submission to be filed within the next three years.

In December 2025, Polpharma Biologics entered into an exclusive licensing agreement with Libbs Farmacêutica, for the commercialisation of an unnamed biosimilar for autoimmune diseases in Brazil.  This deal followed a licensing agreement between Polpharma and MS Pharma in September 2025 for the commercialisation in the MENA region of biosimilars to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®).  In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

Novo Nordisk Secures CHMP Backing for Oral & High-Dose Semaglutide

May 22, 2026

On 22 and 23 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two new formulations of Novo Nordisk’s semaglutide:

The Wegovy® pill is the first oral GLP-1 treatment recommended for approval by CHMP for weight management in the EU. It follows the first-in-world US approval of the oral formulation by the FDA on 23 December 2025 and US launch of the Wegovy® pill on 5 January 2026.  Eli Lilly’s Foundayo™ (orforglipron), the only other oral GLP-1 receptor therapy for weight loss, received US FDA approval on 1 April 2026 and became available to patients on 6 April 2026.

High dose Wegovy® expands the dosing options available in Europe, with Wegovy® currently available only as once-weekly treatment with three separate 2.4 mg injections administered one after each other.  Novo Nordisk expects to launch Wegovy® 7.2 mg in a single-dose pen in Q3 2026 in Europe.  Wegovy® 7.2 mg is already available in the US under the brand name Wegovy® HD.

CHMP Positive Opinions for May 2026 Include Lupin’s Biosimilar Ranibizumab & STADA’s Hybrid Liraglutide

May 22, 2026

On 22 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its May 2026 meeting, including positive opinions for one biosimilar, one “hybrid” medicine and recommended extended indications for a number of biopharmaceuticals.

Lupin’s Vislyfa® (ranibizumab), biosimilar to Genentech’s Lucentis®, was the only biosimilar to receive a positive opinion this month.  There is already a Lupin-developed biosimilar approved in Europe, Ranluspec® (approved February 2026, with planned EU launch in the second half of 2026). Under an August 2025 agreement, Sandoz is commercialising Ranluspec® in the EU (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam and Malaysia.  Other ranibizumab biosimilars approved and launched in Europe include Samsung Bioepis’ Byooviz® (approved August 2021 and commercially available in several European countries since March 2023), STADA/Xbrane’s Ximluci® (launched in the EU in April 2023, following November 2022 approval) and Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva).  Intas’ Rexatilux® (ranibizumab) received a positive CHMP opinion in April 2026.

STADA received positive recommendations for its “hybrid” liraglutide products Ablymico® and STADA Liraglutide™, indicated for weight management and type 2 diabetes, respectively.  The EMA categorises a medicine as “hybrid” where it is similar to an authorised medicine containing the same active substance, but where there are certain differences between the two medicines such as in their strength, indication or pharmaceutical form.  Ablymico® is a hybrid medicine of Novo Nordisk’s Saxenda® (liraglutide), in that it contains the same active substance, but it is chemically synthesised, whereas the active substance of Saxenda® is of biological origin.  For the same reason, STADA Liraglutide™ is a hybrid medicine of Novo Nordisk’s Victoza® (liraglutide).

The CHMP’s May 2026 positive opinions for extended indications include:

Celltrion withdrew its EU marketing authorisation application for Veblocema™ (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis “due to a change in business strategy”, while Laboratoires Delbert withdrew its application for Orblid™ (bevacizumab) for treatment of hereditary haemorrhagic telangiectasia, due to identification of major clinical issues which could only be addressed by carrying out a new clinical study.

New Indication Alert: Mabwell Expands Reach of its Biosimilar Denosumab in China with New Indications

May 21, 2026

On 21 May 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) approved an expanded set of indications for Maiweijian™, biosimilar to Amgen’s Xgeva® (denosumab), developed by its wholly-owned subsidiary T-mab.  The drug is now approved to help delay or reduce skeletal-related events, including pathological fracture, spinal cord compression, and the need for bone surgery or radiotherapy, in patients with bone metastases from solid tumours or multiple myeloma.

This builds on Maiweijian™’s initial NMPA approval in March 2024, when it became the first denosumab biosimilar (120mg) approved for marketing in China, initially indicated for unresectable giant cell tumour of bone.  Mabwell’s Mailishu®, biosimilar to Amgen’s Prolia® (denosumab), was approved by the NMPA in March 2023.

Mabwell announced in April 2026 that it entered into a licensing and commercialisation agreement with an unidentified strategic business partner for Maiweijian™ and Mailishu® in Malaysia.  Under the terms of the agreement, the partner is responsible for the registration and commercialisation of the denosumab biosimilars in Malaysia, while Mabwell is responsible for the development, manufacturing and supply of the biosimilars.

Mabwell completed its first commercial shipment of its denosumab biosimilars outside China in December 2025, although the destination(s) of the shipment was not disclosed in the press release.  According to Mabwell, it has submitted marketing authorisation applications for its denosumab biosimilars in several markets, including Jordan, Egypt, and Brazil.

Samsung Bioepis Launches Ustekinumab Biosimilar in Japan

May 20, 2026

On 20 May 2026, Samsung Bioepis announced that it has launched SB17, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan through its local marketing partner NIPRO Corporation.  SB17 will be marketed in Japan as “Ustekinumab BS Subcutaneous Injection 45 mg “Nipro””.

SB17 was approved in Japan in December 2025 for the treatment of plaque psoriasis and psoriatic arthritis.  The product is being commercialised in Japan by NIPRO under the terms of a June 2025 agreement.

Samsung Bioepis is one of a number of biosimilar competitors launching ustekinumab products in Japan, including Alvotech/Fuji Pharma (May 2024), Biocon/Yoshindo (May 2025), and Celltrion (July 2025).

The Japan launch forms part of Samsung Bioepis’ global launch plans, with Epyztek® (SB17) being the first ustekinumab biosimilar approved in South Korea in April 2024.  SB17 has also been approved in Europe in April 2024 as Pyzchiva®, and a Pyzchiva® autoinjector was launched in May 2025 as the first commercially available biosimilar ustekinumab pre-filled pen in Europe.  In the US, Pyzchiva® was approved in July 2024 and launched in February 2025, in PFS and vial forms.  Under a development and commercialisation agreement with Sandoz entered in September 2023, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.

Zydus Plans Generic Semaglutide Rollout Across 20+ Markets Over Next Two Years

May 20, 2026

On 20 May 2026, The Economics Times reported that Zydus Lifesciences plans to commercialise its generic semaglutide formulation across more than 20 markets over the next two years.

Zydus was one of the first companies to launch generic semaglutide in India (marketed as Semaglyn™, Mashema™ and Alterme™) upon expiry of Novo Nordisk’s key Indian semaglutide patent in March 2026.  Under agreements announced in March 2026, Lupin holds semi-exclusive rights to co-market Zydus’ semaglutide injection in India under the brand names Semanext® and Lupin’s Livarise®, while Torrent Pharmaceuticals holds semi-exclusive rights to co-market the product in India under its own brand name Sembolic™.

Zydus now has global partnerships and registration plans underway for other regions, subject to regulatory approvals.  Sharvil Patel, Managing Director of Zydus, stated that the company expects to “see some launches this year and some in the next year”, although he admitted that Zydus “may not be part of the first wave” of generic semaglutide launches in some markets.  However, Zydus considers its differentiated offering, including its reusable pen device, will “provide significant cost benefits to patients”.

Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

MSD’s Subcutaneous Keytruda® Approved in Korea; Q4/26 Launch Planned

May 20, 2026

On 20 May 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved MSD’s Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) for 35 indications across 18 cancer types.  MSD plans to launch the product in Korea in Q4/2026.

This follows approval of Keytruda SC™ in Canada in February 2026 and in Europe in November 2025.  MSD’s subcutaneous formulation of pembrolizumab was also approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.

Halozyme has commenced patent infringement litigation against MSD in relation to subcutaneous pembrolizumab in Germany and the US.  In December 2025, the Munich Regional Court granted a preliminary injunction to Halozyme, preventing MSD from distributing and offering for sale in Germany Keytruda SC™.  The decision was based on a finding of the Court that there was imminent infringement of one of Halozyme’s European MDASE™ patents, EP 2797622, in relation to modified PH20 hyaluronidase polypeptides and compositions.  Earlier in May 2026, MSD was successful in invalidating one of Halozyme’s US patents before the US Patent Trial and Appeal Board (PTAB).  MSD has a further 17 petitions pending before PTAB.

While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab biosimilars approved or in development.  Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).  Pembrolizumab biosimilars are also in clinical trials including by Formycon, Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.

Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.  Formycon has announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region, Zydus Lifesciences for the US and Canada, and Lotus for the Asia-Pacific.

Pearce IP’s Annual Australian Patent Case Review 2025 – Now Available

May 20, 2026

Pearce IP is pleased to release the Annual Australian Patent Case Review 2025, a comprehensive, expert analysis of all patent decisions shaping the Australian legal landscape over the past year.

Spanning 130 pages, this essential resource provides a complete overview of:

  • All decisions delivered by the Federal Court of Australia
  • All decisions delivered by the Full Court on appeal
  • Significant decisions from the Australian Patent Office

In 2025, the Federal Court delivered 19 substantive patent decisions, alongside 6 key interlocutory decisions, while the Patent Office issued 8 significant rulings. Together, these decisions highlight important developments in patent law.

Our review identifies several major trends and developments regarding:

  • Pharmaceutical patent term extensions (PTEs)
  • Preliminary injunction strategies
  • Computer-implemented inventions
  • Validity challenges
  • Procedural developments
  • Litigation timelines to first instance and appeal decisions, across all registries
  • Forum selection

Complete the form to receive your copy via email.

 

 

If you would like tailored advice on any of the developments covered, our team would be pleased to assist. Contact info@pearceIP.law.

 

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

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

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. 

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Pearce IP BioBlast® for the week ending 15 May 2026

May 19, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 15 May 2026 are set out below:

Aflibercept

On 15 May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety (MFDS) has granted marketing authorisation for Eyzanfy™/ALT-L9 (aflibercept)… Read more here.

Aflibercept, Denosumab, Golimumab

On 11 May 2026, Alvotech announced plans to resubmit Biologics License Applications for aflibercept (AVT06), denosumab (AVT03) and golimumab (AVT05) biosimilars in the… Read more here.

Golimumab

On 18 May 2026, Accord BioPharma announced that the FDA has approved Immgolis™ and Immgolis Intri™ (golimumab) as interchangeable biosimilars to Janssen’s Simponi®… Read more here.

Insulin Lispro, Insulin Aspart

On 15 May 2026, Sandoz announced that the European Commission has granted marketing authorisation for Bysumlog®, biosimilar to Eli Lilly’s Humalog® (insulin lispro), and… Read more here.

Ocrelizumab

On 8 May 2026, Genentech announced that Ocrevus® (ocrelizumab), as IV infusion, has been approved by the FDA for the treatment of relapsing-remitting multiple sclerosis… Read more here.

Pembrolizumab

On 12 May 2026, the US Patent Trial and Appeal Board (PTAB) issued a final written decision invalidating Halozyme’s US Patent No. 11,952,600 relating to modified PH20… Read more here.

Semaglutide

Less than one month after receiving approval for generic equivalents of Novo Nordisk’s Ozempic® in Canada, Apotex and Dr Reddy’s have launched their generic semaglutide… Read more here.

Trastuzumab deruxtecan

On 15 May 2026, the FDA approved BMS/Daiichi Sankyo’s Enhertu® (fam-trastuzumab deruxtecan-nxki) for two separate breast cancer indications. The indications are… Read more here.

Biopharma Deals

On 13 May 2026, Zydus Lifesciences announced that it has entered into a definitive agreement to acquire all outstanding shares of Assertio Holdings in an all-cash transaction… Read more here.
On 12 May 2026, Celltrion announced that it has acquired a 100% stake in France-based healthcare firm, Gifrer. Gifrer operates more than 9,000 pharmacy sales channels… Read more here.
On 12 May 2026, Bristol Myers Squibb (BMS) and Hengrui Pharma announced that they have entered into global strategic collaboration and licence agreements to advance… Read more here.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

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

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. 

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

Chantal Savage

Chantal Savage

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.

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.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Formycon/Klinge Launch Aflibercept Biosimilars in EU

May 19, 2026

On 19 May 2026, Formycon and Klinge Biopharma announced that the European launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), commenced on 15 May 2026 in key European markets, including Germany, France and Italy.

The launch follows a March 2026 settlement agreement between Fomycon/Klinge and Regeneron/Bayer permitting commercialisation of FYB203 in Europe and other licensed regions (including key markets in LATAM and APAC) from May 2026.  FYB203 is set to launch in the US in Q4/2026 following a separate settlement of BPCIA litigation in October 2025.

Formycon/Klinge received European approval for FYB203 in January 2025 under the brand names Ahzantive® and Baiama®.  Formycon developed FYB203 and Klinge holds the exclusive global commercialisation rights.  Klinge has entered into agreements with Teva Pharmaceuticals for the semi-exclusive commercialisation rights to FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel (January 2025), Horus Pharma for the semi-exclusive commercialisation rights to FYB203 (as Baiama®) in selected European countries (September 2025) and NTC for the exclusive commercialisation rights to FYB203 in Italy (November 2025).

Aflibercept biosimilars have been launched in Europe including by Sandoz (Afqlir® launched in UK in November 2025) and Celltrion (Eydenzelt® launched in UK and EU in December 2025).  Settlement agreements between Regeneron/Bayer and other companies also permit further 2026 biosimilar aflibercept launches, including for Samsung Bioepis, Alvotech and Biocon.

Bio-Thera/Accord BioPharma Secure First FDA Approval of Golimumab Biosimilars

May 18, 2026

On 18 May 2026, Accord BioPharma announced that the FDA has approved Immgolis™ and Immgolis Intri™ (golimumab) as interchangeable biosimilars to Janssen’s Simponi® and Simponi® Aria, respectively.  These are the first golimumab biosimilars to be approved in the US.

The BLA for Bio-Thera/Accord’s golimumab biosimilar was accepted by the FDA for review in July 2025, which followed FDA acceptance of Alvotech/Teva’s BLA for AVT05 (golimumab) in January 2025.  However, Alvotech/Teva’s approval was delayed by a Complete Response Letter issued in November 2025, following which Alvotech undertook a “remediation project”.  Alvotech plans to resubmit its golimumab BLA to the FDA in Q2/2026.

Immgolis™ and Immgolis Intri™ were developed by Bio-Thera Solutions as BAT2506.  In February 2025, Bio-Thera and Intas Pharmaceuticals entered into an exclusive US commercialisation and licence agreement for BAT2506, under which Intas’ subsidiary Accord BioPharma is responsible for commercialising the product in the US, while Bio-Thera retains responsibility for development, manufacturing and supply.

The US launch date for Immgolis™ and Immgolis Intri™ is uncertain given ongoing US litigation relating to BAT2506.  In March 2026, Janssen commenced BPCIA patent infringement proceedings against Bio-Thera Solutions/Accord BioPharma alleging infringement of 17 patents.  A preliminary injunction application by Janssen is due to be heard in August or the beginning of September 2026.

Bio-Thera received a positive CHMP opinion in December 2025 for BAT2506, which was EU approved in February 2026 under the name Gotenfia®.  Gotenfia® is commercialised in the EU and UK by STADA.

Product specific reports based on extracts from our BioBlast® database

adalimumab | Humira® | AbbVie

aflibercept | Eylea® | Regeneron

bevacizumab | Avastin® | Roche/Genentech

cetuximab | Erbitux® | BMS/Merck

daratumumab | Darzalex® | J&J

darbepoetin | Aranesp® | Amgen

denosumab | Prolia®/Xgeva® | Amgen

dupilumab | Dupixent® | Sanofi-Aventis

eculizumab | Soliris® | Alexion

etanercept | Enbrel® | Amgen

faricimab | Vabysmo® | Roche

filgrastim (GCSF) | Neupogen® | Amgen

golimumab | Simponi® | Janssen

guselkumab | Tremfya® | Janssen

infliximab | Remicade® | Johnson & Johnson

ixekizumab | Taltz® | Eli Lilly

lecanemab | Leqembi® | Eisai/Biogen

liraglutide | Victoza® /Saxenda® | Novo Nordisk

natalizumab | Tysabri® | Biogen/Elan

nivolumab | Opdivo® | BMS

olaparib | Lynparza® | AstraZeneca/Merck

omalizumab | Xolair® | Genentech / Novartis

pegfilgrastim | Neulasta® | Amgen

pembrolizumab | Keytruda® | MSD

pertuzumab | Perjeta® | Roche

ranibizumab | Lucentis® | Genentech

regdanvimab | Regkirona® | Celltrion

risankizumab | Skyrizi® | AbbVie

rituximab | Rituxan®/MabThera® | Genentech/Biogen

secukinumab | Cosentyx® | Novartis

semaglutide | Wegovy®/Ozempic® | Novo Nordisk

tocilizumab | Actemra® | Roche

trastuzumab | Herceptin® | Roche/Genentech

ustekinumab | Stelara® | Johnson & Johnson/Janssen

vedolizumab | Entyvio® | Takeda

View latest BioBlast® updates

Biosimilars Deals

2025 Deals

2024 Deals

2023 Deals

2022 Deals

2021 Deals

2020 Deals

2019 Deals

2018 Deals

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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