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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...

On 31 August 2026, Taiwan-based Formosa Pharmaceuticals announced that it has submitted a Clinical Trial Application (CTA) to European regulators for a pivotal clinical trial of TSY-110, biosimilar to Roche’s Kadcyla® (trastuzumab emtansine).  Kadcyla® is an antibody ...

On 30 August 2026, Australia’s Minister for Health and Ageing, the Hon Mark Butler, announced that, from 1 September 2026, the listing of MSD’s Keytruda® (pembrolizumab) on the Pharmaceutical Benefits Scheme (PBS) will be expanded to a broad, multi-indication listing for th...

On 28 August 2026, DualityBio announced that it has entered into a global collaboration and licence agreement with Genentech to develop antibody-drug conjugates (ADCs) utilising the “DualityBio Unique Payload Antibody Conjugate” (DUPAC) platform.

Under the agreement,...

On 28 August 2026, the FDA announced that it approved Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC) in children aged 2 years and older. The new paediatric UC indication follows the US approval of Stelara® for paediatric Cr...