Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 14 February 2025 are set out below:
Aflibercept
10 February 2025 | EU | Bayer Submits MAA in Europe for High Dose Eylea™ with Expanded Treatment Intervals
Bevacizumab
12 February 2025 | NZ | NZ’s Pharmac Expands Funding of and Awards “Principal Supply Status” to Celltrion’s Bevacizumab Biosimilar
On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for… Read more here.
Bimekizumab
12 February 2025 | UCB’s Two-Year Data for Bimzelx® Demonstrates Sustained Disease Control in HS
On 12 February 2025, UCB announced that two-year data from the BE HEARD trials for Bimzelx® (bimekizumab) demonstrated sustained disease control in patients with moderate to severe… Read more here.
Brentuximab vedotin
12 February 2025 | US | New Indication Alert: FDA Approves Pfizer’s Adcetris® (Brentuximab Vedotin) Combination Therapy for LBCL
On 12 February 2025, Pfizer announced that the US FDA has approved Adcetris® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of adult patients with… Read more here.
Denosumab
16 February 2025 | EU | Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in EU
On 16 February 2025, Samsung Bioepis announced that the European Commission has approved Obodence™ (60mg pre-filled syringe) and Xbryk™ (120mg vial), biosimilars to Amgen’s Prolia® and… Read more here.
13 February 2025 | US | Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in US
On 13 February 2025, the US FDA approved Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb, SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively. The biosimilars… Read more here.
4 February 2025 | US | Cytiva Subsidiary Seeks to Quash Subpoena Issued in Amgen’s US Denosumab Litigation Against Fresenius Kabi
On 4 February 2025, Cytiva subsidiary media supplier HyClone Laboratories filed a motion in the US District Court for the District of Utah, seeking to quash a subpoena issued to it by Amgen in the… Read more here.
Durvalumab, Cemiplimab, Olaparib, Lecanemab
10 February 2025 | GB-SCT | NHS Scotland to Reimburse Durvalumab, Cemiplimab, and Olaparib; Lecanemab Rejected
On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting… Read more here.
Enfortumab vedotin
10 February 2025 | Pfizer and Astellas Announce Positive Ph 3 Results for Enfortumab Vedotin/Pembrolizumab Combo
On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial evaluated the efficacy and safety of… Read more here.
Garadacimab
13 February 2025 | EU | Approval Alert: CSL’s Garadacimab Approved in Europe
On 13 February 2025, CSL announced that the European Commission has approved Andembry® (garadacimab) to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients… Read more here.
Golimumab
10 February 2025 | US | Bio-Thera and Intas Partner to Commercialise Golimumab Biosimilar in US
On 10 February 2025, Bio-Thera Solutions announced that it has entered an exclusive US commercialisation and licence agreement with Intas Pharmaceuticals for BAT2506 (golimumab)… Read more here.
Insulin aspart
14 February 2025 | US | Approval Alert: FDA Approves Sanofi’s Merilog™/Merilog™ SoloStar as First Rapid Acting Insulin Biosimilars to Novo Nordisk’s Novolog®
On 14 February 2025, the FDA approved Sanofi-Aventis US’s Merilog™ (injection, 10 mL)/Merilog™ SoloStar (injection, 3 mL) (insulin-aspart-szjj), biosimilars to Novo Nordisk’s Novolog® (insulin aspart)… Read more here.
Linvoseltamab
11 February 2025 | US | FDA Accepts Regeneron’s Resubmitted Linvoseltamab BLA
On 11 February 2025, Regeneron announced that the US FDA has accepted for review its resubmitted Biologics Licence Application (BLA) for linvoseltamab. Linvoseltamab, a BCMAxCD3… Read more here.
Nemolizumab
14 February 2025 | EU | Approval Alert: European Commission Approves Galderma’s Nemolizumab
On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis… Read more here.
Pembrolizumab
11 February 2025 | CA | New Indication Alert: Health Canada Approves Merck/MSD’s Keytruda® (Pembrolizumab) for Resectable NSCLC
On 11 February 2025, Merck (known as MSD outside the US and Canada) announced that Health Canada has approved Keytruda® (pembrolizumab) for the treatment of adults with resectable Stage… Read more here.
Tocilizumab
13 February 2025 | KR | Celltrion’s Biosimilar Tocilizumab SC Formulation Approved in Korea
On 13 February 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its subcutaneous formulation for Aptozma™/CT-P47, biosimilar to Roche’s Actemra®… Read more here.
Ustekinumab
12 February 2025 | CN | Approval Alert: China’s NMPA Approves Qyuns Therapeutics’ Biosimilar Ustekinumab for Crohn’s Disease
On 12 February 2025, Qyuns Therapeutics Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorisation application and supplemental… Read more here.
11 February 2025 | AU | Approval Alert: Alvotech/Cipla’s Ustekinumab Biosimilar Approved in Australia
On 11 February 2025, the Australian Therapeutic Goods Administration (TGA) approved Alovtech and Cipla’s Uteknix®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two formulations… Read more here.
Vedolizumab
9 February 2025 | IN | Intas Receives CDSCO Panel Nod for Biosimilar Vedolizumab Ph 1 Study
Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its… 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.