Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the fortnight ending 12 September 2025 are set out below:
Aflibercept
10 September 2025 | UK | Regeneron Files UK Patent Proceedings Against Alvotech and Fisher Clinical Services for Aflibercept Biosimilar
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… Read more here.
9 September 2025 | US | Sandoz’s Biosimilar Aflibercept US Launch Set for Q4 2026 Following Regeneron Settlement
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)… Read more here.
8 September 2025 | AU | Regeneron Aflibercept PI Refused Against Sandoz, AU Market Open to Biosimilars
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® … Read more here.
Certolizumab Pegol
1 September 2025 | IN | India’s CDSCO Approves Lupin’s Ph 1 Trial for Biosimilar Peg Certolizumab
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… Read more here.
Daratumumab
1 September 2025 | EU | EU Approves Ph 3 Trial for Celltrion’s Daratumumab Biosimilar
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® … Read more here.
Denosumab
2 September 2025 | US | FDA Approves Shanghai Henlius/Organon’s Denosumab Biosimilars
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, … Read more here.
1 September 2025 | PK | Mabwell/Searl’s Denosumab Biosimilar Approved in Pakistan
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®… Read more here.
Guselkumab, Ocrelizumab, Vedolizumab
2 September 2025 | MENA | Polpharma Inks Licensing Deal with MS Pharma for Guselkumab, Ocrelizumab and Vedolizumab Biosimilars
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… Read more here.
Nivolumab
4 September 2025 | BR | Counterfeit Opdivo® (Nivolumab) Seized in Brazil
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®… Read more here.
Omalizumab
11 September 2025 | LATAM | Kashiv BioSciences Partners with CRISTÁLIA on Omalizumab Biosimilar in Latin America
On 11 September 2025, Kashiv BioSciences announced that it has entered into a licensing and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA… Read more here.
10 September 2025 | EU | Celltrion Set for 2025 EU Launch of Biosimilar Omalizumab
On 10 September 2025, Celltrion confirmed that it is planning the European launch of Omlyclo® (CT-P39)… Read more here.
Omalizumab, Ustekinumab
4 September 2025 | AU | Celltrion/Arrotex’s Ustekinumab and Omalizumab Biosimilars Launched in Australia
On 4 September 2025, Celltrion announced that it has launched Steqeyma® (ustekinumab) and Omlyclo® (omalizumab) in Australia… Read more here.
Pembrolizumab
5 September 2025 | Pembrolizumab Included on WHO Essential Medicines List
On 5 September 2025, the World Health Organisation (WHO) announced that it has updated its Model List of Essential Medicines (EML) to include pembrolizumab… Read more here.
Secukinumab
10 September 2025 | Celltrion Ph 1 Results for Secukinumab Biosimilar
On 10 September 2025, Celltrion announced that it will present its global Phase 1 clinical trial results for CT-P55… Read more here.
Biopharma Deals
1 September 2025 | CapVest to Acquire Majority Stake in STADA
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 … Read more here.
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
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.
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 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.
Nathan Kan
Lawyer
Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.
Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.