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Apotex’s Denosumab Biosimilar Approved in Canada

Apr 7, 2026

On 7 April 2026, Apotex announced that Health Canada has approved Denoza™, biosimilar to Amgen’s Prolia® (denosumab), for all indications of the reference biologic.

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 the Canadian approvals of Celltrion’s Stoboclo® and Osenvelt® (September 2025) and Henlius/Organon’s Bildyos® and Tuzemty® (HLX14) (March 2026).