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Pearce IP BioBlast® for the week ending 17 October 2025

by , , | Oct 21, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 17 October 2025 are set out below:


Aflibercept

16 October 2025 | AU | LATAM | Formycon/Klinge Partners with Actor in AU and Megalabs in LATAM for Biosimilar Aflibercept
On 16 October 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s… Read more here.
 
13 October 2025 | US | Regeneron to Submit Additional Manufacturer to FDA for Eylea HD® Due to Catalent FDA Action
On 13 October 2025, Regeneron announced that it has been notified by Catalent Indiana, LLC, which was acquired by Novo Nordisk and is the manufacturer filler included in the… Read more here.
 
9 October 2025 | NL | Dutch Court Grants Injunction Preventing Netherlands Launch of Samsung Bioepis’ Biosimilar Aflibercept
On 9 October 2025, The Hague District Court published its decision in legal proceedings between Samsung Bioepis and Regeneron in relation to Regeneron’s Dutch equivalents of… Read more here.

Guselkumab

16 October 2025 | EU | Positive CHMP Opinion for Paediatric Plaque Psoriasis Indication Extension for J&J’s Guselkumab
On 16 October 2025, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the highlights of its October 2025 meeting, including… Read more here.

Insulin Glargine

16 October 2025 | US | Biocon Partners with Civica on Insulin Glargine Biosimilar; US$11 per Pen Pricing in California
On 16 October 2025, Biocon Biologics announced that it is has expanded its collaboration with US-based non-profit pharmaceutical firm Civica, Inc. to supply a new insulin glargine… Read more here.

Nivolumab

14 October 2025 | IN | India’s SEC Approves Phase I/III Trial for Reliance Life Science’s Biosimilar Nivolumab
On 14 October 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has approved… Read more here.

Nivolumab, Ipilimumab

17 October 2025 | AU | PBAC Recommends BMS’ Proposal for Broad Opdivo® (Nivolumab) & Yervoy® (Ipilimumab) Funding
In a significant breakthrough, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) has recommended a broad, multi-indication listing for BMS’ Opdivo® (nivolumab)… Read more here.

BioPharma Deals

17 October 2025 | KR | Samsung Biologics’ Biosimilar Spin-Off Approved at October 2025 EGM
On 17 October 2025, Samsung Biologics announced that its biosimilar operations will be spun off into a new holding entity, Samsung Epis Holdings, after the proposal was approved 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

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

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

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.

 

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