Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 29 November 2024 are set out below:
Belantamab mafodotin
25 November 2024 | US | FDA Accepts BLA for GSK’s Blenrep® Combination Treatment for Multiple Myeloma
On 25 November 2024, GlaxoSmithKline (GSK) announced that the FDA has accepted its BLA for Blenrep® (belantamab mafodotin) in combination with BorDex… Read more here.
Daratumumab
28 November 2024 | Global | Celltrion Phase 3 Clinical Trials for Daratumumab, Biosimilar To Janssen’s Darzalex®
On 28 November 2024, Celltrion announced the commencement of global phase 3 clinical trials for CT-P44, biosimilar to Janssen’s Darzalex® (daratumumab)… Read more here.
Dupilumab
18 November 2024 | US | Regeneron Sues Sanofi For Breach of Dupixent® Collaboration Agreement
Regeneron has sued Sanofi, its partner in the commercialisation of the blockbuster eczema drug Dupixent® (dupilumab), in the US District Court for the Southern District of New York… Read more here.
Lecanemab
28 November 2024 | KR | Eisai Korean Launch of Leqembi for Alzheimer’s Disease
On 28 November 2024, each of Eisai and Biogen announced the launch of Leqembi® (lecanemab) in Korea for the treatment of adult patients with mild cognitive impairment … Read more here.
Olaparib
26 November 2024 | IN | New Indication Alert: AstraZeneca Receives Approval to Market Lynparza (Olaparib) in India
On 26 November 2024, The Economic Times reported that AstraZeneca has received approval from India’s Central Drugs Standard Control Organisation (CSDCO) to market Lynparza®… Read more here.
Omalizumab
26 November 2024 | AU | Approval Alert: Celltrion’s Omlyclo® Is Australia’s First Approved Omalizumab Biosimilar
On 26 November 2024, Celltrion’s Omlyclo®, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab) was approved in Australia. Omlyclo® is the first omalizumab… Read more here.
Semaglutide
27 November 2024 | CA | New Indication Alert: Novo Nordisk’s Wegovy® Approved in Canada
On 27 November 2024, Novo Nordisk Canada announced Canadian approval of Wegovy® (semaglutide) for the reduction of risk of non-fatal myocardial infarction in adults… Read more here.
Tiselizumab
27 November 2024 | EU | New Indication Alert: European Commission Approves BeiGene’s Tevimbra® (Tislelizumab) for ESCC and G/GEJ
On 27 November 2024, BeiGene announced that the European Commission approved Tevimbra® (tislelizumab) in combination with chemotherapy for the first-line treatment… Read more here.
Ustekinumab
26 November 2024 | CN | Acceptance Alert: CSPC Pharmaceutical’s Ustekinumab Biosimilar Accepted by China’s NMPA
On 26 November 2024, CSPC Pharmaceutical Group Limited (CSPC) announced that its biologic license application for ustekinumab (biosimilar to Johnson & Johnson’s Stelara®)… Read more here.
PBAC News
28 November 2024 | AU | Pfizer’s Infliximab, Sandoz’s Natalizumab & Samsung Bioepis’ Ustekinumab on Australia’s PBAC March 2025 Agenda
On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting… 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.