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Biocon’s Denosumab Biosimilars Approved in Canada

Apr 21, 2026

On 21 April 2026, Biocon announced that, on 3 April 2026, Health Canada approved Bosaya™ and Vevzuo™, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  Bosaya™ is approved as a 60mg/mL PFS, while Vevzuo™ is approved as a 120 mg/1.7mL single-dose vial.  No Canadian launch date has been announced.

Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024) were the first denosumab biosimilars approved in Canada, and were launched in August 2024.  This was followed by Canadian approvals of Celltrion’s Stoboclo® and Osenvelt® (September 2025) and Henlius/Organon’s Bildyos® and Tuzemty® (HLX14) (March 2026).  Apotex’s Denoza™, biosimilar to Amgen’s Prolia®, received Canadian approval in early April 2026.

The Canadian approval of Bosaya™ and Vevzuo™ comes just weeks after Biocon’s denosumab biosimilars were launched in the US, under the names Bosaya™ and Aukelso™.  Biocon entered into a settlement and licence agreement with Amgen on 1 October 2025, which permitted Biocon’s US launch of the denosumab biosimilars from 1 October 2025.