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On 3 September 2026, Samsung Bioepis announced that its Ustekinumab BS Intravenous Infusion [NIPRO] (SB17), biosimilar to Janssen’s Stelara®, was approved in Japan as induction therapy for moderate to severely active Crohn’s disease, where other treatments are ineffective.<...

On 3 September 2026, Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, announced that it has entered into a strategic partnership with China’s Qilu Pharmaceutical for the exclusive licensing and supply in the US of QL2107, biosimilar to MSD’s Keytruda® (pembroliz...

On 2 September 2026, South Korean-headquartered Alteogen announced that it has entered into an option and licence agreement with Novartis for the development and commercialisation of subcutaneous (SC) formulations of Novartis products using Alteogen’s ALT-B4 drug delivery t...

On 1 September 2026, Takeda commenced BPCIA proceedings against Alvotech in the US District Court for the District of New Jersey in relation to Alvotech’s AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab).  The litigation against Alvotech follows closely behind Takeda’s ...

On 1 September 2026, AstraZeneca announced that Enhertu® (trastuzumab deruxtecan), developed in conjunction with Daiichi Sankyo, in combination with Roche/Genentech’s Perjeta® (pertuzumab) has been approved by the European Commission for the first-line treatment of adult pa...

On 31 August 2026, South Korean-headquartered Huonslab, a subsidiary of Huons Global, announced that it secured patent registration in Korea, and has filed an international patent application under the Patent Cooperation Treaty (PCT), for its recombinant human-derived hyalu...

On 31 August 2026, Alvotech announced that the FDA has accepted for review its Biologics License Application (BLA) for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab), in prefilled syringe and autoinjector forms for subcutaneous administration.  Alvotech announced posi...