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Paraguay-headquartered Bioéticos, which is part of Laboratorio Productos Eticos C.E.I.S.A (a member of Savone Holding and part of Insud Pharma) claims to have launched the first pembrolizumab biosimilar in Paraguay, under the name Pembrolizumab Bioéticos.  According to a ba...

On 13 August 2025, Shanghai Henlius and Hong Kong-headquartered EssexBio announced that China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted for review their New Drug Application (NDA) for HLX04-0, an ophthalmic preparation ...

On 12 August 2025, Celltrion announced that it has been awarded a series of supply contracts in Italy for its autoimmune disease therapies and oncology treatments.  Key contracts include additional contracts for Steqeyma®, biosimilar to J&J/Janssen’s Stelara® (ustekinum...

On 12 August 2025, Lupin announced that it has partnered with Sandoz to market and commercialise Lupin’s biosimilar ranibizumab (referencing Genentech’s Lucentis®) across the European Union (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam, and...

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 Head of Trade Marks, Kimberley Evans 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...