New Approval Alert: First Xgeva (Denosumab) Biosimilar Approved in Canada

On 4 March 2024, Sandoz announced that Health Canada approved Wyost® as biosimilar to, and for all indications of, Amgen’s Xgeva® (denosumab).

This follows the Canadian approval of Sandoz’s Jubbonti®, biosimilar to Amgen’s Prolia® (denosumab) in February 2024 for osteoporosis and increasing bone mass.

In February 2023 and May 2023 respectively applications for Sandoz’s denosumab biosimilar were accepted by the FDA and EMA.