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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...

On 29 April 2026, Gedeon Richter announced that the European Commission has granted marketing authorisation for Tuyory ®, biosimilar to Roche’s RoActemra® (tocilizumab).  This follows a positive opinion for Tuyory® in February 2026 from the European Medicine Agency’s Commit...

Following the March 2026 launch of several generic equivalents of Novo Nordisk’s Ozempic® (semaglutide) in India and the “tentative approval” of Apotex’s generic semaglutide in the US, the first semaglutide generics have now been approved in Canada.

On 29 April 2026,...

On 29 April 2026, the European Commission approved Shanghai Henlius and Organon’s Poherdy® (pertuzumab) as the first biosimilar to Genentech/Roche’s Perjeta®.

Poherdy® is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or lo...