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On 12 August 2025, the Swiss Federal Patent Court upheld Samsung Bioepis’ invalidity action against the Swiss and Liechtenstein part of Janssen Biotech’s European Patent 3883606.  Janssen’s ‘606 patent relates to the use of ustekinumab (the active ingredient in Stelara®) in...

On 11 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved a new brand of Novartis’ ofatumumab:

ZOPHEOS ofatumumab 20 mg/0.4mL solution for injection pre-filled pen (490662)
ZOPHEOS ofatumumab 20 mg/0.4mL solution for injection pre-fille...

Pearce IP’s Head of Litigation New Zealand, Paul Johns, and our Head of Trade Marks discuss the third party “revival” of the ANSETT brand in 2025 for travel agency services, more than 20 years after the airline folded

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 regulatory developments” and feedback from major regulatory authorities regarding the re...

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 cytokine release syndrome (CRS) in adults and paediatric patients aged 2 years an...

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® (pegfilgrastim), from Coherus Biosciences.  The addition of Udenyca® expands Intas and Ac...

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 to relate to one or more Australian...

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, biosimilar to Takeda’s Entyvio® (vedolizumab).  PB016 was developed by ...

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 is a nonprofit company dedicated to bringing low-cost generic medicines...