Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 18 July 2025 are set out below:
Adalimumab
9 July 2025 | NL | Amsterdam Court Declares PAF’s Claim Against AbbVie Inadmissible
On 9 July 2025, the Amsterdam District Court ruled that the Pharmaceutical Accountability Foundation (PAF) lacked standing in its collective claim against AbbVie regarding the sale of Humira®… Read more here.
Aflibercept
18 July 2025 | KR | Korean Court Refuses Regeneron/Bayer’s Document Requests in Aflibercept Litigation Against Sam Chun Dang
In an article dated 18 July 2025, HiT News reported on a hearing in a patent infringement lawsuit filed by Regeneron and Bayer against Sam Chun Dang (SCD) and Optus Pharmaceutical in the Seoul… Read more here.
Aflibercept, Ranibizumab
17 July 2025 | US | Samsung Bioepis Transitions from Biogen to Harrow for US Commercialisation of Aflibercept/Ranibizumab Biosimilars
On 17 July 2025, Samsung Bioepis announced that it has entered into a licence, development and commercialisation agreement with eyecare pharmaceutical company, Harrow, in relation to Samsung Bioepis’ US ophthalmology… Read more here.
Golimumab
16 July 2025 | US | Bio-Thera/Accord’s Biosimilar Golimumab BLA Accepted for FDA Review
On 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab). BAT2506 is being… Read more here.
Insulin aspart
15 July 2025 | US | Biocon’s Biosimilar Insulin Aspart US-Approved as First Interchangeable Biosimilar to Novo Nordisk’s NovoLog®
On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®… Read more here.
Nivolumab
18 July 2025 | IN | Court Grants Preliminary Injunction Preventing Indian Launch of Zydus’ Biosimilar Nivolumab
On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276) in India. The injunction was granted in… Read more here.
Pembrolizumab
21 July 2025 | Update on Pembrolizumab Biosimilar Clinical Trials
With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the… Read more here.
Tocilizumab
16 July 2025 | Celltrion Announces Results of Ph 3 Tocilizumab Switching Study
On 16 July 2025, Celltrion announced the results of its global phase 3 trial comparing the efficacy and safety of its tocilizumab biosimilar, Avtozma® (CT-P47), to reference drug, Roche’s Actemra®… Read more here.
Biosimilar Policy
14 July 2025 | EU | Samsung Bioepis Whitepaper Proposes EU Biosimilar Reforms
On 14 July 2025, Samsung Bioepis published a whitepaper entitled “Solving the Biosimilar Void in Europe”, which proposes various recommendations for European biosimilar policy reform… 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.