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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...

On 26 August 2026, Biocon announced that it received marketing authorisation from Japan’s Ministry of Health, Labour and Welfare for its pegfilgrastim biosimilar, referencing Amgen’s Neulasta® (known as G-Lasta® in Japan).  The biosimilar will be exclusively marketed in Jap...

On 26 August 2026, the Economic Times reported that India’s CDSCO has approved Dr Reddy’s biosimilar to BMS’ Orencia® (abatacept) for the treatment of moderate to severely active rheumatoid arthritis and active psoriatic arthritis in patients who have responded inadequately...

On 25 August 2026, Celltrion announced that it has launched Omlyclo® 300 mg, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in Europe, commencing in Germany, the UK and France.

Omlyclo® was the first (and remains the only) omalizumab biosimilar to be approve...

On 24 August 2026, Celltrion announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab).  This is the second biosimilar pembrolizumab application filed in Korea, following Samsung Bioepis’ ...