Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 25 April 2025 are set out below:
Aflibercept
18 April 2025 | US | FDA Issues CRL for Extended Dosing Intervals of Regeneron’s Eylea HD®
On 18 April 2025, Regeneron announced that it received a complete response letter (CRL) from the US FDA regarding the supplemental Biologics Licence Application (sBLA) for Eylea HD® (aflibercept… Read more here.
15 April 2025 | US | Biocon Settles Biosimilar Aflibercept BPCIA Litigation with Regeneron; Yesafili™ US Launch H2 2026
On 15 April 2025, Biocon announced that it has entered a settlement and licence agreement with Regeneron, agreeing to dismiss pending US BPCIA litigation regarding its Eylea® (aflibercept) biosimilar, Yesafili™… Read more here.
Denosumab
25 April 2025 | EU | Positive CHMP Opinions for 8 Denosumab Biosimilars
On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab… Read more here.
15 April 2025 | RU | Approval Alert: Petrovax Pharm’s Biosimilar Denosumab First to Receive Russian Approval
On 15 April 2025, Petrovax Pharm announced that it is launching its denosumab biosimilar (Forsedeno®) in the Russian market after the Russian Ministry of Health granted marketing … Read more here.
Dupilumab
18 April 2025 | US | New Indication Alert: FDA Approves Regeneron/Sanofi’s Dupixent (Dupilumab) for Chronic Spontaneous Urticaria
On 18 April 2025, Sanofi and Regeneron announced that Dupixent (dupilumab) received FDA approval as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU)… Read more here.
Natalizumab, Omalizumab, Ustekinumab
24 April 2025 | AU | Australia’s PBAC Recommends Reimbursement of Biosimilars to Natalizumab, Omalizumab and Ustekinumab
On 24 April 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) March 2025 meeting were published, including recommendations for the listing of three biosimilars… Read more here.
Nivolumab, Ipilimumab
22 April 2025 | UK | NICE Recommends Funding of Opdivo® and Yervoy® for Colorectal Cancer
The UK’s National Institute for Health and Care Excellence has recommended NHS funding for Bristol Myers Squibb’s immunotherapy combination Opdivo® (nivolumab) and Yervoy® (ipilimumab… Read more here.
Pembrolizumab
24 April 2025 | US | MSD/Merck Sued for US Patent Infringement Over SC Pembrolizumab
On 24 April 2024, Halozyme Therapeutics announced that it has sued MSD (known as Merck in the US and Canada) for patent infringement in the US District Court for the District of New Jersey… Read more here.
Trastuzumab
25 April 2025 | EU | CuraTeQ’s Biosimilar Trastuzumab Receives Positive CHMP Opinion in EU
At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Aurobindo Pharma’s subsidiary CuraTeQ’s Dazublys®… Read more here.
Ustekinumab
24 April 2025 | US | Samsung Bioepis Publishes Quarterly US Biosimilar Market Report; Steep WAC Discounts for Newly Launched Ustekinumab Biosimilars
On 24 April 2025, Samsung Bioepis published its ninth quarterly US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and… Read more here.
Biopharma Deals 2025
16 April 2025 | Polpharma and Chime Partner to Develop Undisclosed Biosimilar
On 16 April 2025, Shanghai-based CDMO, Chime Biologics, announced that it has entered a strategic cooperation agreement with Polpharma Biologics “to advance the end-to-end development and… 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
Graduate (Law)
Nathan is a Graduate (Law) 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.