Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 31 January 2025 are set out below:
Adalimumab, Nivolumab
31 January 2025 | AU | Australia’s PBAC Recommends New and Amended PBS Listings for AbbVie’s Humira®; BMS’ Opdivo® Rejected for NSCLC
Aflibercept
30 January 2025 | EU | Amgen’s Aflibercept Biosimilars Receive Positive CHMP Opinions
29 January 2025 | US | US Appeals Court Refuses to Overturn Injunctions Against Samsung Bioepis’ and Formycon’s Aflibercept Biosimilars
On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn preliminary injunctions preventing Samsung Bioepis and Formycon from … Read more here.
Datopotamab deruxtecan, Tisotumab vedotin
30 January 2025 | EU | CHMP Positive Opinions for AZ/Daiichi Sankyo & Pfizer’s Cancer Drugs; Expanded Indications for AZ, BMS & Roche
At its January 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for four new medicines and… Read more here.
Durvalumab
22 January 2025 | UK | UK’s NICE Recommends AstraZeneca’s Imfinzi® for SCLC
On 22 January 2025, PMLive reported that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Imfinzi® (durvalumab) in combination with chemotherapy… Read more here.
Epcoritamab
30 January 2025 | NZ | Approval Alert: AbbVie’s Epkinly® (Epcoritamab) Provisionally Approved in New Zealand
On 30 January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection… Read more here.
Garadacimab
24 January 2025 | UK | Approval Alert: CSL Receives UK Approval for Garadacimab
On 24 January 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved CSL’s Andembry® (garadacimab) for patients aged 12 years and… Read more here.
Isatuximab
31 January 2025 | CN | UK | New Indication Alert: Sanofi’s Isatuximab Combination Therapy for Multiple Myeloma Approved in China and the UK
On 31 January 2025, Sanofi announced that China’s National Medical Products Administration (NMPA) has approved Sanofi’s Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, … Read more here.
Lecanemab
28 January 2025 | EU | US | Eisai/Biogen’s Leqembi® FDA Approved for Monthly IV Maintenance Dosing; Under Further Consideration in EU
On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Eisai/Biogen’s Leqembi® (lexanemab)… Read more here.
Marstacimab
29 January 2025 | AU | Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Approved in Australia
Omalizumab
30 January 2025 | UK | Court Denies Celltrion’s Application to Revoke UK Omalizumab Patent
Semaglutide
28 January 2025 | US | New Indication Alert: FDA Approves Novo Nordisk’s Ozempic® for Kidney Disease
Tocilizumab
31 January 2025 | US | Approval Alert: Celltrion’s Biosimilar Tocilizumab Third to be Approved in US
Trastuzumab deruxtecan
28 January 2025 | USA | New Indication Alert: AstraZeneca/Daiichi Sankyo’s Enhertu® FDA Approved for Breast Cancer
On 27 and 28 January 2025, AstraZeneca and Daiichi Sankyo announced that the US FDA has approved Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable… 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.