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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...

Regeneron and Bayer have withdrawn a preliminary injunction (PI) application against Sandoz in Germany in relation to Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).  According to a JUVE Patent report of 27 March 2026, the result is that Sandoz ...

On 25 March 2026, the Australian Pharmaceutical Benefits Assessment Committee (PBAC) published the agenda for its July 2026 meeting, with three biosimilars submitted for consideration.

One of the biosimilars will be considered for the first time, Biocon’s Yesintek®, ...

On 24 March 2026, Regeneron and Sanofi announced that the Japanese Ministry of Health, Labour and Welfare has approved Dupixent® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP).  Dupixent® is also approved in Japan for certain patient...

On 24 March 2026, Shanghai Henlius Biotech announced that Health Canada has approved Bildyos® and Tuzemty® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, across all reference indications.

Under a June 2022 agreement, Organon has exclusiv...