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On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276) in India.  The injunction was granted in proceedings brought by BMS alleging Zydus’ Indian launch of its nivolumab biosim...

In an article dated 18 July 2025, HiT News reported on a hearing in a patent infringement lawsuit filed by Regeneron and Bayer against Sam Chun Dang (SCD) and Optus Pharmaceutical in the Seoul Central District Court.  The lawsuit was filed by Regeneron/Bayer in January 2024...

On 17 July 2025, Samsung Bioepis announced that it has entered into a licence, development and commercialisation agreement with eyecare pharmaceutical company, Harrow, in relation to Samsung Bioepis’ US ophthalmology portfolio.  The agreement follows Biogen’s October 2024 d...

On 16 July 2025, Celltrion announced the results of its global phase 3 trial comparing the efficacy and safety of its tocilizumab biosimilar, Avtozma® (CT-P47), to reference drug, Roche’s Actemra®.  The results demonstrated comparable efficacy, pharmacokinetics, safety and ...

On 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab).  BAT2506 is being developed and manufactured by Bio-Thera and will be commercialised in th...

On 16 July 2025, the US District Court for the District of New Jersey made consent orders reflecting a settlement of the patent infringement litigation brought by Amgen against Accord and Intas relating to Accord/Intas’ biosimilar denosumab.  While the terms of the settleme...

On 15 July 2025, Biocon Biologics announced that the FDA has approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable biosimilar to Novo Nordisk’s NovoLog®.

Kirsty™ (100 units/mL) will be available as a single-patient-use prefilled pen for subcuta...