On 30 October 2025, New Zealand’s Medsafe approved Celltrion’s Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively. This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in New Zealand, following Sandoz’s Jubbonti® and Wyost® in May 2025.
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), Australia (approved April 2025, not yet launched) and Canada (approved September 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, permitting the US launch of Celltrion’s denosumab biosimilars in July 2025.