Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 8 August 2025 are set out below:
Adalimumab
4 August 2025 | EU | Celltrion’s Adalimumab Vying for Top Spot in EU
On 4 August 2025, Celltrion announced that, according to market research firm IQVIA, Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), reached 24% market share in Europe in Q1 2025, up… Read more here.
Aflibercept
5 August 2025 | AU | Actor Commences Legal Action Against Regeneron/Bayer in Australia
On 5 August 2025, Actor Pharmaceuticals filed legal proceedings against Regeneron and Bayer in the Australian Federal Court. While the details of the proceedings have not yet been published, it is expected that the proceedings are likely… Read more here.
4 August 2025 | US | Update on Challenges to Regeneron’s US Aflibercept Patents
On 14 July 2025, Fresenius Kabi filed petitions for IPR (inter partes review) against Regeneron’s US Patent No. 11,084,865 to ophthalmic formulations of aflibercept and US Patent No. 10,828,345 to… Read more here.
Denosumab
1 August 2025 | KR | Boryung Launches Samsung Bioepis’ Xbryk™ (Denosumab) in South Korea
On 1 August 2025, the Korea Biomedical Review reported that Boryung launched Samsung Bioepis’ denosumab biosimilar (Xbryk™) in the Korean market, following its regulatory approval in May 2025… Read more here.
Nivolumab, Ocrelizumab
7 August 2025 | Sandoz Streamlines Clinical Trials for Nivolumab and Ocrelizumab Biosimilars
On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its nivolumab and ocrelizumab biosimilars, following “ongoing encouraging and favourable… Read more here.
Omalizumab
5 August 2025 | MENA | Kashiv & MS Pharma Enter Licensing Deal for Biosimilar Omalizumab in MENA Region
On 5 August 2025, Kashiv BioSciences and MS Pharma announced that they entered into a licence and supply agreement for Kashiv’s ADL-018, biosimilar to Novartis’ Xolair® (omalizumab), for the… Read more here.
4 August 2025 | AU | Celltrion’s Omalizumab PFP Approved in AU
On 4 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in two pre-filled pen (PFP)… Read more here.
Pegfilgrastim
6 August 2025 | Intas and Accord Acquire Pegfilgrastim Biosimilar from Coherus Biosciences
On 6 August 2025, Intas Pharmaceuticals, and its global subsidiaries operating under the Accord brand, announced the successful acquisition of Udenyca®, biosimilar to Amgen’s Neulasta®… Read more here.
Tocilizumab
6 August 2025 | US | New Indication Alert: FDA Approves Celltrion’s Biosimilar Tocilizumab IV Formulation for CRS
On 6 August 2025, Celltrion announced that the US FDA has approved an expanded indication for its IV formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of… Read more here.
Ustekinumab
5 August 2025 | US | Fresenius Kabi to Launch Unbranded Ustekinumab Biosimilar in US via CivicaScript
On 5 August 2025, CivicaScript, LLC announced that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz, biosimilar to J&J/Janssen’s Stelara®, in the US from 1 January 2026. CivicaScript… Read more here.
Vedolizumab
5 August 2025 | Fresenius Kabi takes Global Licence to Polpharma’s Vedolizumab Biosimilar
On 5 August 2025, Polpharma Biologics and Fresenius Kabi announced that they have entered into a global licensing agreement (excluding Middle East & North Africa) for the commercialisation of PB016… 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 Attorney (AU, NZ) & Trade Mark Attorney (AU)
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
Lawyer
Nathan is a lawyer 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.