Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 28 March 2025 are set out below:
Denosumab
26 March 2025 | US | Approval Alert: FDA Approves Denosumab Biosimilars for Fourth Sponsor
On 26 March 2025, Fresenius Kabi announced that the US FDA approved its Biologics Licence Application (BLA) for Conexxence® and Bomyntra® (denosumab-bhnt), biosimilars to Amgen’s… Read more here.
Denosumab, Ustekinumab
27 March 2025 | EU | Positive Opinions for Accord’s Denosumab and Celltrion’s Ustekinumab Biosimilars in EU
At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars… Read more here.
Golimumab, Ustekinumab
26 March 2025 | ASIA | Bio-Thera and Dr Reddy’s Enter SE Asia Commercialisation Agreement for Golimumab and Ustekinumab Biosimilars
On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s… Read more here.
Mepolizumab
24 March 2025 | EU | EMA Accepts GSK’s Mepolizumab Indication Expansion Application for COPD
On 24 March 2025, GSK announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala® (mepolizumab) as an add-on maintenance… Read more here.
Ocrelizumab
27 March 2025 | AU | Roche’s High Dose Ocrelizumab Approved in Australia
On 27 March 2025, Australia’s Therapeutic Goods Administration (TGA) approved Roche’s high dose Ocrevus® (ocrelizumab) in a 920mg/23ml solution for injection. This adds to the 300mg/10ml formulation… Read more here.
Omalizumab
26 March 2025 | UK | Alvotech/Kashiv/Advanz’s Omalizumab Biosimilar MAA Accepted in UK
On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23… Read more here.
Pembrolizumab
27 March 2025 | US | FDA Accepts Merck/MSD’s BLA for SC Pembrolizumab; Decision Expected September 2025
On 27 March 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab… Read more here.
Tocilizumab
27 March 2025 | EU | EMA Accepts Gedeon Richter’s Application for Biosimilar Tocilizumab
On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s… 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.