Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 11 April 2025 are set out below:
Adalimumab
14 April 2025 | US | Celltrion Secures US Interchangeability for Biosimilar Adalimumab Yuflyma®
On 14 April, Celltrion announced that it has secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free adalimumab biosimilar, Yuflyma®… Read more here.
Aflibercept
8 April 2025 | EU | Bayer Seeks EU Approval of Eylea™ 8mg (Aflibercept) for RVO
On 8 April 2025, Bayer announced that it has filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) for… Read more here.
4 April 2025 | EU | Approval Alert: Amgen’s Biosimilar Aflibercept Approved in EU
On 4 April 2025, the European Commission granted marketing authorisation to Amgen’s Pavblu® (aflibercept 2mg), biosimilar to Bayer/Regeneron’s Eylea® for nAMD and visual impairment… Read more here.
Daratumumab
7 April 2025 | EU | EC Approves Expanded Multiple Myeloma Indication for J&J’s Darzalex® (Daratumumab) Quadruplet Regimen
On 7 April 2025, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with… Read more here.
Denosumab
10 April 2025 | CuraTeQ Biologics Completes Biosimilar Denosumab Phase I Trial
On 10 April 2025, Aurobindo subsidiary, CuraTeQ Biologics, reported its successful Phase I results for BP16, biosimilar to Amgen’s Prolia® (denosumab)… Read more here.
Eculizumab
7 April 2025 | US | Teva/Samsung Bioepis Launch Epysqli® (Eculizumab-aagh) in US
On 7 April 2025, Teva and Samsung Bioepis announced the US launch of Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®. According to the joint announcement, Epysqli® will be offered… Read more here.
Etanercept
14 April 2025 | US | Sandoz Sues Amgen in US for Anti-Competitive Conduct In Blocking Biosimilar Etanercept Launch
On 14 April 2025, Sandoz announced that it has filed an antitrust lawsuit against Amgen in the US District Court for the Eastern District of Virginia in relation to etanercept. Sandoz’s complaint… Read more here.
Nivolumab, Ipilimumab
8 April 2025 | US | New Indication Alert: FDA Approves BMS’ Opdivo® (Nivolumab) Plus Yervoy® (Ipilimumab) for Colorectal and Hepatocellular Cancer
On 8 and 11 April 2025, respectively, BMS announced that the FDA has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment in two new indications… Read more here.
Ustekinumab
8 April 2025 | EU | Hague Court of Appeal Rules Samsung Bioepis can Manufacture and Stockpile its Ustekinumab Biosimilar for Export
Samsung Bioepis has successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s… Read more here.
8 April 2025 | UK | Accord/Dong-A ST’s Biosimilar Ustekinumab Launched in UK and Ireland
On 8 April 2025, The Bio reported that Dong-A ST has launched Imuldosa®, biosimilar to J&J’s Stelara® (ustekinumab) in the UK and Ireland, following its launch in Germany in January 2025… 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.