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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...

On 28 August 2026, Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SB35, biosimilar to Eli Lilly’s Taltz® (ixekizumab).  The trial has an estimated primary completion date of June 2027 and will compare the pharmacokinetics, safety, tolerability, and...

On 26 August 2026, Takeda commenced BPCIA proceedings against Polpharma in the US District Court for the District of New Jersey in relation to Polpharma’s PB016, biosimilar to Takeda’s Entyvio® (vedolizumab).  Takeda alleges infringement of six US patents relating to vedoli...

On 26 August 2026, OncLive reported that Chia Tai Tianqing Pharmaceutical’s TQB2440 showed equivalent efficacy to its reference drug, Roche/Genentech’s Perjeta® (pertuzumab), in a Phase 3 clinical trial, when combined with trastuzumab and docetaxel as neoadjuvant therapy fo...