Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 19 September 2025 are set out below:
Aflibercept
21 September 2025 | IN | CA | Biocon’s Biosimilar Aflibercept Recommended in India; Publicly Funded in Canada
On 21 September 2025, Medical Dialogues reported that Biocon has received recommendations from India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation… Read more here.
18 September 2025 | AU | Samsung Bioepis’ Aflibercept Biosimilar Third to be Approved in Australia
On 18 September 2025, Samsung Bioepis’ Opuviz®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), was approved by Australia’s Therapeutic Goods Administration (TGA) in 2 presentations… Read more here.
17 September 2025 | AU | Regeneron/Bayer Appeal Australian Court’s Refusal to Grant PI and Prevent Launch of Sandoz’s Biosimilar Aflibercept
On 17 September 2025, Regeneron filed an application for leave to appeal the decision of Justice Rofe of the Federal Court of Australia refusing to award Regeneron/Bayer a preliminary injunction against Sandoz… Read more here.
17 September 2025 | US | Alvotech Files US PGR Challenging Regeneron’s Method of Treatment Patent for High Dose Aflibercept
On 17 September 2025, Alvotech filed a petition for post grant review of Regeneron’s patent… Read more here.
17 September 2025 | EU | Alteogen’s Biosimilar Aflibercept EU Approved
On 17 September 2025, Alteogen announced that the European Commission has approved Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)… Read more here.
17 September 2025 | EU | Formycon/Klinge’s Biosimilar Aflibercept to be Commercialised by Horus Pharma in EU
On 17 September 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)… Read more here.
Denosumab
19 September 2025 | EU | European Commission Approves Shanghai Henlius/Organon’s Denosumab Biosimilars
On 19 September 2025, Shanghai Henlius and Organon announced that the European Commission has approved Bildyos® and Bilprevda® (HLX14)… Read more here.
19 September 2025 | CuraTeQ Announces Positive Ph 3 Results for Biosimilar Denosumab
On 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16… Read more here.
18 September 2025 | CA | Celltrion’s Denosumab Biosimilars Second to be Approved in Canada
On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s… Read more here.
17 September 2025 | US | FDA Approves Biocon’s Denosumab Biosimilars Bosaya™ and Aukelso™
On 17 September 2025, Biocon Biologics announced that it received FDA approval for denosumab products Bosaya™ and Aukelso™, biosimilars to Amgen’s… Read more here.
Golimumab, Denosumab, Ustekinumab
19 September 2025 | EU | Positive CHMP Opinions for 9 Biosimilars – Good News for Alvotech, Advanz, STADA, Dr Reddy’s, Teva, Intas & Bio-Thera
On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting… Read more here.
Golimumab, Denosumab, Aflibercept
19 September 2025 | JP | Alvotech/Fuji Pharma’s JP Golimumab Biosimilar First Approved Worldwide; Aflibercept & Denosumab Biosimilars Also JP Approved
On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars … Read more here.
Omalizumab
19 September 2025 | NO | Celltrion Launches Biosimilar Omalizumab in Norway; Presents Ph 3 Results from Switching Study
On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway… Read more here.
Pembrolizumab
19 September 2025 | US | EU | MSD’s Subcutaneous Keytruda® (Pembrolizumab) Approved in US & Recommended in EU
On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults… Read more here.
Secukinumab
15 September 2025 | MENA | Bio-Thera & Jamjoom Pharma Partner on Secukinumab Biosimilar in MENA
On 15 September 2025, Bio-Thera and Saudi Arabia-headquartered Jamjoom Pharmaceuticals Factory Company announced they have entered a strategic commercialisation… Read more here.
Tocilizumab
22 September 2025 | JP | Celltrion’s Biosimilar Tocilizumab First to be Approved in Japan
On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® … Read more here.
Ustekinumab
16 September 2025 | JP | Mitsubishi Tanabe’s Co-Promotion of Janssen’s Stelara® to End on 31 December 2025 in Japan
On 16 September 2025, First Word Pharma reported that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara®… Read more here.
10 September 2025 | NL | Dutch Court Validates Janssen’s Ustekinumab Patent for Treating UC
On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent)… 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.