Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 3 October 2025 are set out below:
Aflibercept
2 October 2025 | US | Formycon/Klinge/Valorum Set for Q4/2026 Biosimilar Aflibercept US Launch Following Regeneron Settlement
On 2 October 2025, Formycon announced that it and its licence partners, Klinge Biopharma and Valorum Biologics, have entered a settlement and licence agreement with Regeneron… Read more here.
Bevacizumab
29 September 2025 | US | Outlook Therapeutics to Resubmit Ophthalmic Bevacizumab BLA to FDA Before End 2025
On 29 September 2025, Outlook Therapeutics announced that it has completed a Type A Meeting with the FDA to discuss the August 2025 complete response letter (CRL)… Read more here.
Denosumab
1 October 2025 | US | Biocon Launches Denosumab Biosimilars in US Following Amgen Settlement
On 1 October 2025, Biocon announced that it has entered into a settlement and licence agreement with Amgen that resolves pending BPCIA patent litigation and permits… Read more here.
29 September 2025 | US | Richter/Hikma’s Biosimilar Denosumab Seventh Approved in US
On 29 September 2025, Gedeon Richter and Hikma Pharmaceuticals announced they have secured FDA approval for Enoby™ (RGP-14-P) and Xtrenbo™… Read more here.
29 September 2025 | US | US Reimbursement Boost for Fresenius’ Biosimilar Denosumab
On 29 September 2025, Fresenius Kabi announced that the US Centers for Medicare and Medicaid Services (CMS) assigned a permanent billing code for… Read more here.
5 September 2025 | US | Samsung Bioepis & Amgen Settle BPCIA Denosumab Litigation
On 5 September 2025, consent orders were made by the US District Court for the District of New Jersey recording that Samsung Bioepis and Amgen… Read more here.
Etanercept
1 October 2025 | AU | Sandoz’s Biosimilar Etanercept PBS-Listed
On 1 October 2025, Sandoz’s Erelzi®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was listed on Australia’s Pharmaceutical Benefits Scheme… Read more here.
Guselkumab
29 September 2025 | US | New Indication Alert: FDA Extends J&J’s Guselkumab to PsO and PsA in Children
On 29 September 2025, Johnson & Johnson announced that the US FDA has approved an indication extension for Tremfya® (guselkumab) for the treatment of… Read more here.
Nivolumab, Ipilimumab
1 October 2025 | US | PTAB Grants Amgen Adverse Judgment Against BMS’ Disclaimed Nivolumab/Ipilimumab Patent
On 1 October 2025, the US Patent Trial and Appeal Board (PTAB) issued its decision in the inter partes review (IPR), filed by Amgen in February 2025 and instituted in July 2025… Read more here.
Secukinumab
29 September 2025 | US | Novartis to Launch US Direct Sales Platform for Secukinumab
On 29 September 2025, Novartis announced that it plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from 1 November 2025… Read more here.
Tocilizumab
3 October 2025 | US | Celltrion Launches IV Tocilizumab Biosimilar in US
On 3 October 2025, Celltrion announced that it has launched its intravenous formulation of Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in the United States… Read more here.
Ustekinumab
3 October 2025 | AU | Samsung Bioepis Successfully Opposes Grant of Janssen’s AU Ustekinumab Patent Application
On 3 October 2025, IP Australia delivered its decision in Samsung Bioepis’ opposition to the grant of Janssen’s AU2019346134 relating to a method of treating ulcerative colitis… Read more here.
3 October 2025 | CSPC Pharmaceutical’s Biosimilar Ustekinumab Ph 3 Results
On 3 October 2025, Pharmacy Times reported that CSPC Pharmaceutical Group’s SYSA1902 has been shown in a phase 3 study to be clinically equivalent to its reference product… Read more here.
BioPharma Deals
6 October 2025 | MENA | Celltrion & Hikma Expand MENA Partnership to Include 6 Additional Biosimilars
On 6 October 2025, Hikma Pharmaceuticals and Celltrion Inc, announced that they have entered exclusive licensing agreements for 6 biosimilars… Read more here.
29 September 2025 | Genmab to Acquire Merus in USD 8B Deal
On 29 September 2025, Genmab A/S and Merus N.V. announced that they have entered into an agreement for Genmab to acquire all the shares of Merus… 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.