Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 7 March 2025 are set out below:
Aflibercept
5 March 2025 | US | US Appeals Court Affirms Injunction Preventing Launch of Celltrion’s Aflibercept Biosimilar
On 5 March 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Celltrion from launching its biosimilar to Regeneron’s Eylea® (aflibercept) in… Read more here.
COVID-19 mRNA Vaccine; Respiratory Syncytial Virus Vaccine
3 March 2025 | CA | JP | CH | EU | Genevant/Arbutus Files 5 International Infringement Actions Against Moderna Relating to LNP Technology
On 3 March 2025, Genevant Sciences and Arbutus Biopharma announced that they have jointly filed five international lawsuits seeking to enforce patents protecting their lipid nanoparticle (LNP) technology against… Read more here.
Denosumab
7 March 2025 | US | Amgen and Fresenius Kabi Settle US BPCIA Denosumab Litigation
On 7 March 2025, the US District Court for the District of New Jersey ordered the dismissal of all claims and counterclaims in Amgen’s BPCIA patent infringement proceeding against Fresenius Kabi… Read more here.
3 March 2025 | US | Approval Alert: Celltrion’s Biosimilar Denosumab Third to be Approved in US
On 3 March 2025, Celltrion announced that it has received US FDA approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the… Read more here.
3 March 2025 | US | FDA Accepts Amneal/mAbxience’s Denosumab BLA for Review
On 3 March 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has accepted for review their aBLA for two new denosumab biosimilars referencing Amgen’s Prolia® and Xgeva®… Read more here.
Eculizumab
5 March 2025 | US | Amgen Launches First US Eculizumab Biosimilar with Interchangeability
On 5 March 2025, Generics Bulletin reported that Amgen has launched Bkemv® (eculizumab-aeeb) in the US as the first available interchangeable biosimilar to Alexion’s Soliris®… Read more here.
4 March 2025 | US | New Indication Alert: Soliris® (Eculizumab) Approved in US for Paediatric Myasthenia Gravis
On 4 March 2025, NeurologyLive reported that the US FDA has approved an expanded indication of Alexion/AstraZeneca’s Soliris® (eculizumab) to include both adult and paediatric patients 6 years of… Read more here.
Lecanemab
6 March 2025 | UK | Eisai/Biogen’s Leqembi® Receives Further Reimbursement Consideration by UK’s NICE for Early Alzheimer’s Disease
On 6 March 2025, the UK’s National Institute for Health and Care Excellence (NICE) opened a second consultation period in respect of the use of Eisai/Biogen’s Leqembi® (lecanemab) on the NHS in… Read more here.
3 March 2025 | AU | Eisai/Biogen’s Leqembi® (Lecanemab) Rejected by Australia’s TGA
On 3 March 2025, Eisai and Biogen announced that Australia’s Therapeutic Goods Administration (TGA) has confirmed its initial decision to decline the approval of Leqembi® (lecanemab) for the… Read more here.
Liraglutide
6 March 2025 | AU | Approval Alert: Sun Pharma Achieves First Generic Liraglutide Approval in Australia
On 6 March 2025, Sun Pharma’s liraglutide became the first approved generic to Novo Nordisk’s Saxenda® in Australia. The product was approved by Australia’s Therapeutic Goods… Read more here.
Nivolumab, Ipilimumab
7 March 2025 | EU | New Indication Alert: BMS’ Opdivo®/Yervoy® Combo EU-Approved for First Line Treatment of Unresectable/Advanced HCC
On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with… Read more here.
28 February 2025 | US | Amgen Challenges Validity of BMS’ US Patents for Methods of Treatment Using Opdivo®/Yervoy®
On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of Bristol Myers Squibb’s US patents relating to methods of treatment using nivolumab and… Read more here.
Omalizumab
7 March 2025 | US | Approval Alert: FDA Approves Celltrion’s Omlyclo® as First Interchangeable Omalizumab Biosimilar
On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab). Omlyclo® is approved as a… Read more here.
Pembrolizumab
5 March 2025 | US | Merck (MSD) and Halozyme in US Patent Dispute as Subcutaneous Pembrolizumab Launch Approaches
On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered Merck (known as MSD outside the US and Canada) an opportunity to licence patents owned by Halozyme… Read more here.
Risankizumab
4 March 2025 | CA | AbbVie Launches Skyrizi® (Risankizumab) in Canada for UC
On 4 March 2025, AbbVie announced that Skyrizi® (risankizumab) is now available in Canada for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had… Read more here.
Tislelizumab
4 March 2025 | US | New Indication Alert: FDA Approves BeiGene’s Tevimbra® for ESCC
On 4 March 2025, BeiGene announced that the US FDA has approved its Tevimbra® (tislelizumab), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with … Read more here.
Ustekinumab
7 March 2025 | Biocon Announces Positive Ph 3 Results for Biosimilar Ustekinumab
On 7 March 2025, Biocon Biologics announced the results of a Phase 3 study comparing Yesintek™ (biosimilar ustekinumab) with J&J/Janssen’s Stelara® in adults with moderate to severe chronic … Read more here.
3 March 2025 | Formycon/Fresenius Kabi Launches Fourth Biosimilar Ustekinumab in US
On 3 March 2025, Fresenius announced the US launch of Otulfi®/FYB202 (ustekinumab-aauz), biosimilar to J&J/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 & Trade Mark Attorney (AU, NZ)
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.