Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 29 August 2025 are set out below:
Aflibercept
28 August 2025 | KR | Bayer’s Eylea® 8mg PFS (OcuClick) Approved in Korea
On 28 August 2025, Bayer announced that it has received approval from Korea’s Ministry of Food and Drug Safety for its OcuClick pre-filled syringe (PFS) presentation of Eylea® 8mg (aflibercept). The… Read more here.
Bevacizumab
28 August 2025 | US | FDA Issues Second Complete Response Letter to Outlook Therapeutics for Ophthalmic Bevacizumab
On 28 August 2025, Outlook Therapeutics announced that the US FDA issued a complete response letter (CRL) declining its BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™… Read more here.
Daratumumab
22 August 2025 | RU | BIOCAD Obtains Approval of First Daratumumab Biosimilar
On 22 August 2025, BIOCAD announced that the Russian Ministry of Health has approved Daratumia®, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), as the first daratumumab… Read more here.
Denosumab
1 September 2025 | AU | Amgen’s Supplemental Denosumab Brands PBS-Listed following Sandoz Biosimilar Launch
On 1 September 2025, Australia’s Pharmaceutical Benefits Scheme published its summary of changes for the month of September. Among the changes was the PBS-listing of Amgen’s… Read more here.
26 August 2025 | TH | Abbott’s Denosumab Biosimilar First to be Approved in Thailand
On 26 August 2025, Abbott announced that it has secured regulatory approval for the first denosumab biosimilar, referencing Amgen’s Prolia®/Xgeva®, in Thailand… Read more here.
Guselkumab
28 August 2025 | UK | UK’s NICE Recommends Janssen’s Guselkumab for Crohn’s and UC Within NHS
On 28 August 2025, the UK’s NICE published guidance recommending J&J/Janssen’s Tremfya® (guselkumab) for use within England’s NHS for previously treated moderately to severely active Crohn’s disease… Read more here.
Nivolumab, Ipilimumab
25 August 2025 | JP | New Indication Alert: Opdivo®/Yervoy® Combo Approved in Japan for MSI-High CRC
On 25 August 2025, Ono Pharma and Bristol-Myers Squibb announced that they received supplemental approval in Japan for Opdivo® (nivolumab) and Yervoy® (ipilimumab) in combination therapy… Read more here.
Trastuzumab
26 August 2025 | UK | CuraTeQ’s Trastuzumab Biosimilar UK Approved
On 26 August 2025, Medical Dialogues reported that Aurobindo Pharma subsidiary, CuraTeQ Biologics, has received marketing approval from the UK’s MHRA for Dazublys®, biosimilar to… Read more here.
Trastuzumab, Infliximab
28 August 2025 | VN | Celltrion Launches Trastuzumab and Infliximab Biosimilars in Vietnam
On 28 August 2025, Celltrion announced that it has launched two biosimilars in Vietnam… Read more here.
Ustekinumab
26 August 2025 | EU | Bio-Thera/Richter’s Biosimilar Ustekinumab EU Approved
On 26 and 27 August 2025, Bio-Thera Solutions and Gedeon Richter announced that the European Commission (EC) has approved BAT2206, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). The… Read more here.
12 August 2025 | CH | Samsung Bioepis Invalidates Janssen Ustekinumab Patent in Switzerland
On 12 August 2025, the Swiss Federal Patent Court upheld Samsung Bioepis’ invalidity action against the Swiss and Liechtenstein part of Janssen Biotech’s European Patent 3883606. Janssen’s ‘606… 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.