Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 20 December 2024 are set out below:
Aflibercept
20 December 2024 | US | LATAM | Fresenius & SamChunDang Exclusive US & LATAM Licence for Aflibercept Biosimilar
On 20 December 2024, Fresenius Kabi announced that it had entered into a licensing agreement with SamChunDang Pharm (SCD) to exclusively commercialise South Korean developed… Read more here.
Amivantamab
16 December 2024 | US | CRL for J&J’s Subcutaneous Rybrevant® (Amivantamab)
Concizumab
21 December 2024 | US | Approval Alert: Novo Nordisk’s Alhemo® (Concizumab) Gets US FDA Approval
On 21 December 2024, Novo Nordisk announced that the US FDA has approved its Alhemo® (concizumab) injection as a once-daily prophylactic treatment to prevent or reduce the frequency of bleeding… Read more here.
Donanemab
17 December 2024 | CN | Approval Alert: Eli Lilly’s Kisunla® (Donanemab) Approved in China
On 17 December 2024, Eli Lilly announced that China’s National Medical Products Administration (NMPA) has approved its donanemab-azbt Kisunla® (350 mg/20 mL every four weeks injection for IV… Read more here.
Dostarlimab
16 December 2024 | US | GSK’s Jemperli® (Dostarlimab) receives US FDA Breakthrough Therapy Designation
On 16 December 2024, GSK announced that the US FDA has granted Breakthrough Therapy Designation to Jemperli® (dostarlimab) for the treatment of patients with locally advanced mismatch… Read more here.
Golimumab
On 16 December 2024, Johnson & Johnson (J&J) announced that it submitted a supplemental Biologics Licence Application (sBLA) to the US FDA seeking the approval of Simponi® (golimumab) for… Read more here.
Nivolumab, Ipilimumab, Inotuzumab ozogamicin
19 December 2024 | NZ | New Zealand’s Pharmac Seeks Feedback on Funding Proposals for BMS’ Opdivo® & Yervoy®, and Pfizer’s Besponsa®
On 19 December 2024, New Zealand’s Pharmac issued a media release requesting feedback on proposals to fund six medicines for cancer and antibiotic resistant infections from 1 April 2025, which includes:… Read more here.
Olaparib
11 December 2024 | US | AstraZeneca and Merck (MSD) Report Positive Phase 3 Results for Olaparib in Early Breast Cancer
On 11 December 2024, AstraZeneca and Merck (known as MSD outside the US and Canada) announced positive results for Lynparza® (olaparib) in the treatment of breast cancer, as.. Read more here.
Pertuzumab
5 December 2024 | IN | CDSCO Panel Approves Zydus’ Safety Study of Pertuzumab Biosimilar
Sacituzumab govitecan
17 December 2024 | US | Gilead’s Trodelvy® (Sacituzumab Govitecan-hziy) Granted FDA Breakthrough Therapy Designation
On 17 December 2024, Gilead Sciences announced that the US FDA has granted Breakthrough Therapy Designation (BTD) to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult… Read more here.
Ustekinumab
15-17 December 2024 | EU | US | Approval Alerts: Accord and Celltrion’s Ustekinumab Biosimilars Approved in EU and US, Biocon Receives EU Recommendation
On 15 December 2024, Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of… Read more here.
20 November 2024 | CA | JAMP Loses Canadian ‘Abuse of Dominance’ Application Against Janssen Regarding Stelara® (Ustekinumab)
We reported on 26 August 2024 that JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara®… Read more here.
PBAC News
20 December 2024 | AU | Australia’s PBAC Recommends Sandoz’s Denosumab and Celltrion’s Ustekinumab Biosimilars Among November Outcomes
On 20 December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its November 2024 meeting, recommending listing for one biosimilar,… Read more here.
18 December 2024 | AU | Originators Dominate PBAC’s May 2025 Agenda
On 18 December 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the May 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.