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On 8 May 2026, Genentech announced that Ocrevus® (ocrelizumab), as IV infusion, has been approved by the FDA for the treatment of relapsing-remitting multiple sclerosis (RRMS) in paediatric patients aged 10 years and older who weigh at least 25 kg.

Ocrevus® was first...

On 7 May 2026, Daiichi Sankyo announced that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) received approval from Korea’s Ministry of Food and Drug Safety on 30 April 2026 for the treatment of HER-2 positive metastatic breast cancer and gastric ca...

On 5 May 2026, Reuters reported that, from 1 July 2026, CVS Health will preference lower-cost, interchangeable biosimilars over Johnson & Johnson’s (J&J) Stelara® (ustekinumab) in ‌its most common drug lists.  CVS Health’s pharmacy benefit management unit, Caremark,...

On 4 May 2026, Lannett Company, with its wholly owned subsidiary, Lanexa Biologics, and Sunshine Lake Pharma (the pharmaceutical business arm of HEC Group) announced that the FDA has approved Langlara™ (insulin glargine-aldy), as an interchangeable biosimilar to Sanofi’s La...

On 1 May 2026, Janssen/Johnson & Johnson (J&J) announced that, on 15 April 2026, the FDA approved Stelara® (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease.  Stelara® is now the only FDA-approved IL-1...

On 1 May 2026, Aurobindo announced that its subsidiary, CuraTeQ Biologics, received Canadian approval for Bevqolva™ (bevacizumab), biosimilar to Genentech’s Avastin®.  Bevqolva™ is indicated for various cancers and is available in 100 mg and 400 mg formulations.

Cura...

On 30 April 2026, Celltrion announced that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™).

The timing of the ap...

On 30 April 2026, Xbrane announced that it has resubmitted its BLA for biosimilar ranibizumab 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.  However...