On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.
This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in Canada, following Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024), which were launched in August 2024.
Celltrion’s denosumab biosimilars have been approved in various regions, including: Korea (approved November 2024, launched March 2025), Europe (approved February 2025, not yet launched), the US (approved March 2025, launched July 2025) and Australia (approved April 2025, not yet launched).
In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab. That litigation settled in January 2025, supporting the US launch of Celltrion’s denosumab biosimilars in July 2025.