Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 20 June 2025 are set out below:
Adalimumab
16 June 2025 | DE | German Court Rules Samsung Bioepis/Biogen’s Adalimumab Biosimilar Infringes Fresenius Formulation Patent
On 16 June 2025, Korea Biomedical Review reported that the Dusseldorf Higher Regional Court ruled that Samsung Bioepis/Biogen’s Imraldi®, biosimilar to AbbVie’s Humira® (adalimumab), infringes a formulation patent held in Germany by Fresenius Kabi… Read more here.
Aflibercept
23 June 2025 | AU | Regeneron & Bayer Seek Interlocutory Injunction to Prevent AU Launch of Sandoz’s Aflibercept Biosimilar
On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for… Read more here.
17 June 2025 | US | Regeneron Files New US BPCIA Complaint Against Amgen for Pavblu™, Eylea® Biosimilar
On 17 June 2025, Regeneron filed a new BPCIA complaint against Amgen in the United States District Court for the Central District of California, asserting that Amgen’s Pavblu™/ABP 938 (aflibercept)… Read more here.
Aflibercept, Ustekinumab
20 June 2025 | EU | Positive CHMP Opinions for Four Aflibercept Biosimilars, and One Ustekinumab Biosim
On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars… Read more here.
Clesrovimab, Mepolizumab
19 June 2025 | AU | MSD’s Clesrovimab Accepted for Review Alongside Expanded Indication for GSK’s Nucala® (Mepolizumab)
On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for March, April and May 2025… Read more here.
Eculizumab
19 June 2025 | EU | UPC Court of Appeal Refuses Rehearing in Alexion’s Eculizumab Patent Infringement Actions Against Samsung Bioepis and Amgen
On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary… Read more here.
Nivolumab, Ipilimumab, Omalizumab
20 June 2025 | AU | Australia’s PBAC Recommends Reimbursement of BMS’ Opdivo®/Yervoy® Combo for Stage III Melanoma; Novartis’ Xolair® Recommended for CRSwNP
On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab)… Read more here.
Ustekinumab, Etanercept, Natalizumab
20 June 2025 | AU | Ustekinumab, Etanercept and Natalizumab Biosimilars Up for July PBS-Listing
Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®)… 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
Law Graduate
Nathan is a law graduate focused on providing 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.