Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 5 December 2025 are set out below:
Aflibercept
On 5 December 2025, Korea’s HIT News reported that Samsung Bioepis has successfully overturned a preliminary injunction granted to Regeneron and Bayer which was… Read more here.
On 26 November 2025, Boan Biotech announced that Boyoujing® (BA9101), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by China’s National… Read more here.
Denosumab
On 2 December 2025, Biocon announced that it has reached a settlement and licence with Amgen for Europe and ROW, permitting Biocon to launch its Evfraxy® and… Read more here.
On 24 November 2025, consent orders were made by the US District Court for the District of New Jersey recording that Hikma Pharmaceuticals and Gedeon Richter have… Read more here.
Infliximab
On 2 December 2025, Celltrion announced that it has launched Remsima® SC (infliximab) in Chile, marking the biosimilar’s first entrance into the public market in Central and South… Read more here.
Omalizumab
Pembrolizumab
On 4 December 2025, Halozyme announced that the Munich Regional Court has granted its application for a preliminary injunction to prevent MSD from distributing and… Read more here.
On 4 December 2025, Formycon and MS Pharma announced that they have entered into an exclusive licensing and supply agreement for the commercialisation of FYB206… Read more here.
Pegfilgrastim
On 1 December 2025, Lupin announced that the US FDA has approved Armlupeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in 6 mg/0.6 mL pre-filled syringe (PFS) form.. Read more here.
Ranibizumab
On 2 December 2025, Samsung Bioepis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion… Read more here.
Tocilizumab
On 4 December 2025, New Zealand’s Medsafe approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in vial (intravenous) and pre-filled syringe (subcutaneous)… Read more here.
Trastuzumab
On 8 December 2025, Celltrion announced that it intends to expand its biosimilar pipeline by “internalising” hyaluronidase-based subcutaneous delivery (SC) formulation technology… Read more here.
Ustekinumab
1 December 2025 | US | Express Scripts adds Accord Biosimilar Ustekinumab to Formularies
On 1 December 2025, Accord BioPharma announced that Express Scripts has added Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), to its largest commercial… Read more here.
BioPharma Deals
6 December 2025 | Biocon Limited to Wholly Acquire Biocon Biologics, Valued at USD 5.5B
On 6 December 2025, Biocon Limited announced that Biocon Biologics will be integrated into it, becoming a wholly owned subsidiary of the company upon completion of the transaction… Read more here.
About Pearce IP
Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.
In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.
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 specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.