Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 7 February 2025 are set out below:
Aflibercept
8 February 2025 | Regeneron Presents Positive Phase 3 Results for EYLEA HD®
5 February 2025 | APAC | Klinge and Lotus Pharma Partner to Commercialise Aflibercept Biosimilar in Key APAC Countries
On 5 February 2025, Formycon announced that its partner, Klinge Biopharma has entered an exclusive licence agreement with Taiwan-based Lotus Pharmaceutical for the commercialisation of … Read more here.
Amivantamab
3 February 2025 | EU | New Indication Alert: J&J’s Subcutaneous Rybrevant® Recommended in the EU for NSCLC
On 3 February 2025, Johnson & Johnson (J&J) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an indication… Read more here.
Daratumumab
6 February 2025 | EU | US | Shanghai Henlius and Dr Reddy’s Enter Licence Agreement for Biosimilar Daratumumab
On 6 February 2025, Shanghai Henlius announced that it has entered into a licence agreement with Dr. Reddy’s for HLX15, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab) and… Read more here.
Denosumab
6 February 2025 | US | Amgen’s BPCIA Denosumab Litigation Against Samsung Bioepis, Fresenius & Accord Centralised in New Jersey
On 6 February 2025, the US Judicial Panel on Multijurisdictional Litigation granted Amgen’s request to centralise its BPCIA litigation alleging that each of Samsung Bioepis, Fresenius… Read more here.
Pembrolizumab
4 February 2025 | Merck/MSD’s Worldwide Keytruda® Sales Grow 18% to US$29.5 Billion in 2024
On 4 February 2025, Merck (known as MSD outside the US and Canada) revealed its Q4 and full year 2024 financial results, including reporting that global Keytruda® (pembrolizumab) sales for 2024 grew 18%… Read more here.
Shanghai Henlius Biotech announced on 2 February 2025 that the US FDA has accepted its Biologic Licence Application (BLA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab)… Read more here.
Ranibizumab
4 February 2025 | US | New Indication Alert: FDA Approves Genentech’s Susvimo® (Ranibizumab) for DME
On 4 February 2025, Genentech (a member of the Roche group) announced that the US FDA approved a new indication for Susvimo® (ranibizumab, 100mg/ml injection). Susvimo® is the first … Read more here.
Rozanolixizumab
7 February 2025 | AU | Approval Alert: UCB’s Rystiggo® (Rozanolixizumab) Approved in Australia
Serplulimab
5 February 2025 | EU | Henlius’ Serplulimab Becomes EU’s First Anti PD-1 mAb Approved for ES-SCLC
Company News
5 February 2025 | Novo Nordisk’s Sales Increase 26% in 2024, Led by 56% Growth in Wegovy®/Saxenda®
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.