Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 26 September 2025 are set out below:
Adalimumab
22 September 2025 | AU | Amgen’s High-Concentration Adalimumab Biosimilar AU Approved
On 22 September 2025, Australia’s Therapeutic Goods Administration approved Amgen’s high-concentration Amgevita® (100mg/ml), biosimilar to AbbVie’s Humira® (adalimumab), in the following… Read more here.
Aflibercept
25 September 2025 | DE | German Court Grants Cross-Border PI Preventing Launch of Formycon’s Biosimilar Aflibercept
On 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203, biosimilar to Regeneron/Bayer’s Eylea®… Read more here.
24 September 2025 | AU | Celltrion’s Application for Biosimilar Aflibercept Indication Extension Under Review in Australia
On 24 September 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for the months of July, August and September… Read more here.
23 September 2025 | JP | KR | Sam Chun Dang’s Biosimilar Aflibercept Approved in Japan and Korea
On 23 September 2025, Korea Biomedical Review reported that Sam Chun Dang’s SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) was approved in both Japan and Korea… Read more here.
Bevacizumab, Ocrelizumab, Pertuzumab & More
24 September 2025 | NZ | New Zealand’s Pharmac Proposing to Fund Multiple Roche Biologics
New Zealand’s drug funding agency, Pharmac, has opened for public consultation a provisional agreement with Roche to fund a package of Roche drugs, including subcutaneous formulations… Read more here.
Canakinumab
23 September 2025 | RU | First Canakinumab Biosimilar Approved in Russia
On 23 September 2025, GxP News reported that Russian company, Generium, has obtained registration of the first Russian biosimilar to Novartis’ Ilaris® (canakinumab)… Read more here.
Guselkumab
19 September 2025 | US | New Indication Alert: FDA Approves J&J’s Subcutaneous Guselkumab for UC
On 19 September 2025, Johnson & Johnson announced that the FDA has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) … Read more here.
Nivolumab
23 September 2025 | CA | Subcutaneous Nivolumab Recommended for Reimbursement in Canada for Solid Tumour Indications
On 23 September 2025, Bristol Myers Squibb announced that the Institut national d’excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of Opdivo® SC… Read more here.
Omalizumab
26 September 2025 | US | Amneal Submits US BLA for Omalizumab Biosimilar
On 26 September 2025, Amneal Pharmaceuticals announced that it submitted a Biologics License Application (BLA) to the US FDA for ADL-018 (omalizumab), biosimilar to Novartis’ Xolair®… Read more here.
Pembrolizumab
26 September 2025 | CN | Shanghai Henlius Kicks Off Pembrolizumab Biosimilar Trials in China
On 26 September 2025, Shanghai Henlius announced that the first patient has been dosed in its phase 1 multicentre clinical trial for HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab)… Read more here.
24 September 2025 | IN | Intas Required to Revise Biosimilar Pembrolizumab Trial Protocol in India
On 24 September 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has instructed Intas Pharmaceuticals to submit a revised protocol… Read more here.
Pertuzumab
22 September 2025 | IN | Enzene’s Pertuzumab Biosimilar Launched in India
On 22 September 2025, Enzene Biosciences announced the Indian launch of its biosimilar to Roche’s Perjeta® (pertuzumab). According to Enzene, the biosimilar is being marketed in India by… 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.