Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 31 October 2025 are set out below:
Aflibercept
On 1 November 2025, HITNews reported that Samsung Bioepis has overturned a 2024 decision of the Korean Intellectual Property Trial and Appeal Board (IPTAB) which found that… Read more here.
On 27 October 2025, the FDA issued a Complete Response Letter (CRL) to Regeneron for its pre-filled syringe (PFS) supplementary BLA (sBLA) for Eylea HD® (aflibercept, 8mg)… Read more here.
Aflibercept, Ranibizumab
On 29 October 2025, Samsung Bioepis announced that it has entered into an Asset Purchase Agreement with Biogen in Europe for Samsung Bioepis’ two ophthalmology… Read more here.
Denosumab
On 31 October 2025, Accord’s denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®, were approved by Australia’s Therapeutic Goods Administration (TGA) as follows… Read more here.
On 30 October 2025, New Zealand’s Medsafe approved Celltrion’s Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively… Read more here.
The FDA has approved denosumab biosimilars Conexxence® and Bomyntra® (Fresenius Kabi) and Stoboclo® and Osenvelt® (Celltrion) as interchangeable with Amgen’s Prolia®… Read more here.
On 29 October 2025, GlycoNex announced that the last patient has received the final dose in its phase 3 clinical study of SPD8 , biosimilar to Amgen’s Prolia®/Xgeva® (denosumab)… Read more here.
Nivolumab
On 30 October 2025, Boan Biotech announced that it has completed enrolment for the clinical phase III study of its self-developed BA1104, biosimilar to BMS’ Opdivo® (nivolumab)… Read more here.
Ranibizumab, Brolucizumab
On 27 October 2025, China Medical System Holdings Limited announced that its subsidiary, CMS Vision International Management Limited, has entered into a distribution agreement with… Read more here.
Biosimilar Regulation
On 29 October 2025, the FDA announced proposed measures to make it faster and less costly to develop biosimilars, by simplifying biosimilarity studies, reducing unnecessary… 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 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.