Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 21 February 2025 are set out below:
Aflibercept
21 February 2025 | KR | Korean Court Rules in Favour of Samsung Bioepis in Aflibercept Biosimilar Patent Dispute
On 21 February 2025, Korean Economic Daily reported that Samsung Bioepis has succeed in a patent dispute regarding Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept). Regeneron had… Read more here.
20 February 2025 | CA | Health Canada Approves Bayer/Regeneron’s Eylea® HD PFS with OcuClick™
On 20 February 2025, Bayer announced that Health Canada has approved Eylea® HD (aflibercept injection, 8mg) in a pre-filled syringe with integrated OcuClick™ dosing system for the treatment of… Read more here.
18 February 2025 | US | FDA to Review Alvotech/Teva’s BLA for Biosimilar Aflibercept
On 18 February 2025, Alvotech and Teva announced that the US FDA has accepted for review a Biologics Licence Application (BLA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea®… Read more here.
18 February 2025 | EU | Approval Alert: European Commission Approves Celltrion’s Aflibercept Biosimilar
On 18 February 2025, Celltrion announced that the European Commission has approved Eydenzelt® (CT-P42), biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), for the treatment of multiple retinal… Read more here.
Belantamab mafodotin, Mirvetuximab soravtansine and More
19 February 2025 | AU | GSK’s Blenrep® and AbbVie’s Elahere® Under Review in AU; Expanded Indications for 4 More Biologics
Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the month of January. Among the applications for new medicines to be… Read more here.
Bevacizumab
19 February 2025 | BO | Approval Alert: Henlius’ Biosimilar Bevacizumab Achieves First Overseas Approval in Bolivia
On 19 February 2025, Shanghai Henlius Biotech announced that its HANBEITAI, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has received marketing approval from Bolivia’s Agencia… Read more here.
Denosumab
19 February 2025 | EU | Approval Alert: Celltrion’s Denosumab Biosimilars Third to be Approved in Europe
On 19 February 2025, Celltrion announced that the European Commission has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for… Read more here.
Dupilumab
18 February 2025 | US | Regeneron/Sanofi’s Dupixent® sBLA Accepted for Priority Review for Treating Bullous Pemphigoid
On 18 February 2025, Regeneron and Sanofi announced that the US FDA has accepted their sBLA for priority review of Dupixent® (dupilumab) for the targeted treatment of bullous pemphigoid (BP)… Read more here.
Epcoritamab
20 February 2025 | JP | New Indication Alert: Genmab’s Epkinly® (Epcoritamab) Approved in Japan for R/R Follicular Lymphoma
On 20 February 2025, Genmab announced that Japan’s Ministry of Health, Labour and Welfare has approved Epkinly® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) … Read more here.
Garadacimab
20 February 2025 | JP | Approval Alert: CSL’s Garadacimab Approved in Japan
On 20 February 2025, CSL announced that its Andembry® (garadacimab) has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in subcutaneous 200mg injection pens for… Read more here.
Mepolizumab
20 February 2025 | CN | GSK’s Nucala® (Mepolizumab) Under Review in China for COPD
On 20 February 2025, GSK announced that China’s National Medical Products Administration (NMPA) has accepted for review a new drug application for the use of Nucala® (mepolizumab)… Read more here.
Nemolizumab
18 February 2025 | UK | CH | Approval Alert: Galderma’s Nemolizumab Approved in the UK and Switzerland
On 18 February 2025, Galderma announced that Nemluvio® (nemolizumab) for subcutaneous administration has been approved in the UK and Switzerland for two indications:… Read more here.
Pembrolizumab
17 February 2025 | US | Formycon to Terminate Ph 3 Trial and Pursue US-Approval of Pembrolizumab Biosimilar Based on Ph 1/Analytical Data
On 17 February 2025, Formycon announced that it will be prematurely terminating the “Lotus” Phase 3 trial of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab). According to Formycon… Read more here.
Petosemtamab
18 February 2025 | US | Merus’ Petosemtamab Granted FDA Breakthrough Therapy Designation for HNSCC in Combination with Pembrolizumab
On 18 February 2025, Merus announced that the FDA has granted Breakthrough Therapy Designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment … Read more here.
Semaglutide
21 February 2025 | US | FDA Removes Novo Nordisk’s Ozempic® and Wegovy® From Drug Shortages List
On 21 February 2025, the FDA announced that the US semaglutide injection product shortage has resolved, such that semaglutide can now be removed from the drug shortages list. The FDA has… Read more here.
17 February 2025 | AU | New Indication Alert: Novo Nordisk’s Wegovy® AU-Approved for Heart Disease
The Australian Financial Review reports that on 17 February 2025, Novo Nordisk confirmed that Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® (semaglutide)… Read more here.
Ustekinumab
21 February 2025 | US | Alvotech/Teva’s Selarsdi® is Second Ustekinumab Biosimilar Launched in US
On 21 February 2025, Alvotech and Teva announced the US launch of Selarsdi® (AVT04, ustekinumab-aekn for injection), biosimilar to J&J/Janssen’s Stelara®… Read more here.
18 February 2025 | EU | Approval Alert: Biocon’s Ustekinumab Biosimilar Approved in Europe
On 18 February 2025, Biocon Biologics announced that the European Commission has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Yesintek®… 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.