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On 31 March 2026, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in October 2025.  In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026.  How...

Shanghai Henlius and Organon have settled US BPCIA litigation brought by Amgen in June 2025 in relation to their denosumab biosimilars, Bilprevda® and Bildyos® (HLX14), as recorded by a Consent Order and Judgment filed with the US District Court for the District of New Jers...

In a LinkedIn post on 30 March 2026, Gedeon Richter announced that it expects its ustekinumab biosimilar “to become progressively available across European markets starting from March 2026”.

Gedeon Richter is commercialising the ustekinumab biosimilar in Europe under...

On 30 March 2026, Celltrion announced that it launched its high dose (300 mg) Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in Korea, as reported by Korea Biomedical Review.

The Korean launch follows the January 2026 Canadian approval of high dose...

On 30 March 2026, Teva Pharmaceutical Industries announced that the FDA has approved Ponlimsi™, biosimilar to Amgen’s Prolia® (denosumab).  At the same time, Teva also announced that its regulatory applications for a biosimilar to Genentech/Novartis’ Xolair® (omalizumab) ha...

At its March 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted the EMA’s April 2025 “Reflection paper on a tailored clinical approach in biosimilar development”.  Stakeholders had been invited to provide comm...

On 27 March 2026, Celltrion announced that Japan’s Ministry of Health, Labour and Welfare has approved two of its biosimilars: Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), and Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg.

On 27 March 2026, Novo Nordisk announced that the FDA has approved Awiqli® (insulin icodec-abae) injection 700 units/mL as the first and only once-weekly, long acting basal insulin for adults with type 2 diabetes.

The US approval follows the issue of a Complete Respo...

On 27 March 2026, Johnson & Johnson announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Darzalex® (daratumumab) subcutaneous (SC) formulation.  The update enables patients with multiple mye...

On 27 March 2026, Daiichi Sankyo announced the conditional approval in China of Enhertu® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) for the neoadjuvant treatment of HER2 positive stage 2 or 3 breast cancer.  According to Daiichi Sankyo...