Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 28 February 2025 are set out below:
Adalimumab
1 March 2025 | AU | Sandoz’s 80mg/0.8mL (100mg/mL) Biosimilar Adalimumab PBS-Listed
On 1 March 2025, Sandoz’s high-concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) 100mg/mL (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira®… Read more here.
Aflibercept
25 February 2025 | UK | Approval Alert: Formycon/Klinge Pharma’s Aflibercept Biosimilar Approved in UK
On 25 February 2025, Formycon and Klinge Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ahzantive®/FYB203 (aflibercept)… Read more here.
Bevacizumab
28 February 2025 | US | Outlook Therapeutics Resubmits US BLA for Ophthalmic Bevacizumab
On 28 February 2025, Outlook Therapeutics announced that it has resubmitted its Biologics Licence Application (BLA) to the US FDA for ONS-5010 (Lytenava™, ophthalmic bevacizumab-vikg) for the… Read more here.
Garadacimab
26 February 2025 | CH | Approval Alert: CSL’s Andembry® (Garadacimab) Approved in Switzerland
On 26 February 2025, CSL announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Andembry® (garadacimab) for long-term prophylaxis of recurring attacks of hereditary… Read more here.
Isatuximab
25 February 2025 | JP | New Indication Alert: Sanofi’s Sarclisa® Combination Therapy for MM Approved in Japan
On 25 February 2025, Sanofi announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Sarclisa® (isatuximab), in combination with bortezomib, lenalidomide, and… Read more here.
Lecanemab
28 February 2025 | EU | CHMP Reaffirms Positive Opinion for Biogen/Eisai’s Leqembi® (Lecanemab) for Early Alzheimer’s Disease
On 28 February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for Leqembi® (lecanemab) for… Read more here.
Linvoseltamab
28 February 2025 | EU | Positive CHMP Opinion for Regeneron’s Linvoseltamab (Lynozyfic®)
On 28 February 2025, Regeneron announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation of Lynozyfic®… Read more here.
Liraglutide
28 February 2025 | UK | Biocon Launches Generic of Novo Nordisk’s Diabetes and Obesity Drug Liraglutide in UK
On 28 February 2025, Biocon announced that it has launched its liraglutide products in the UK. The products are generic versions of Novo Nordisk’s Victoza®, to treat type 2 diabetes, and Saxenda®,… Read more here.
Nivolumab, Ipilimumab
24 February 2025 | US | FDA Accepts sBLA for Opdivo® and Yervoy® for Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
BMS has announced that the FDA has accepted a supplemental biologics licence application (sBLA) for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment option for… Read more here.
Odronextamab
26 February 2025 | US | Regeneron’s Odronextamab BLA Resubmission Accepted for FDA Review
On 26 February 2025, Regeneron announced that the US FDA has accepted for review the resubmission of the BLA for odronextamab for the treatment of relapsed/refractory follicular… Read more here.
Pembrolizumab
25 February 2025 | US | MSD’s sBLA for Keytruda® for HNSCC Granted FDA Priority Review
On 25 February 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted for priority review a Biologics Licence Application (sBLA) for Keytruda® (pembrolizumab)… Read more here.
25 February 2025 | US | Merck/MSD’s Keytruda® to Undergo Government Price Setting in 2026
On 25 February 2025, Merck (known as MSD outside the US and Canada), published its 2024 Annual Report, which revealed the company’s expectation that Keytruda® (pembrolizumab) will be selected in… Read more here.
Semaglutide
24 February 2025 | US | Semaglutide Compounders Sue FDA Over Removal of Novo Nordisk’s Ozempic® and Wegovy® from US Drug Shortages List
Following the FDA’s decision on 21 February 2025 to remove Novo Nordisk’s semaglutide products (Ozempic® and Wegovy®) from the Drug Shortages List, the regulator has been sued by the… Read more here.
Tocilizumab
24 February 2025 | EU | Approval Alert: Celltrion’s Biosimilar Tocilizumab EU-Approved
On 24 February 2025, Celltrion announced that the European Commission has approved Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab). Avtozma® is approved for all indications of… Read more here.
Ustekinumab
24 February 2025 | US | J&J & Janssen Sue Samsung Bioepis in US For Private Label Ustekinumab
On 24 February 2025, Johnson & Johnson (J&J) and Janssen Biotech filed a complaint in the US District Court for the District of New Jersey alleging that Samsung Bioepis has breached a settlement and licence… Read more here.
24 February 2025 | US | Samsung Bioepis/Sandoz’s and Biocon’s Ustekinumab Biosimilars Launched in US
On 24 February 2025, Sandoz announced the US launch of Pyzchiva® (ustekinumab-ttwe), biosimilar to J&J/Janssen’s Stelara®. On the same date, Biocon Biologics announced the US launch… Read more here.
Ustekinumab, Durvalumab, Trastuzumab Deruxtecan, Glofitamab & More
28 February 2025 | EU | CHMP Recommends Expanded Indications for Janssen’s Stelara®, Darzalex® & Tremfya®; AZ’s Imfinzi®; Daiichi’s Enhertu®; Roche’s Columvi®
At its February 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended expanded therapeutic indications for 16 medicines, including the… 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.