On 29 May 2025, New Zealand’s Medsafe approved Sandoz’s Jubbonti® and Wyost®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively. This makes Sandoz’s Jubbonti® and Wyost® the first denosumab biosimilars approved in New Zealand.
Sandoz’s Jubbonti® and Wyost® are approved in the US (March 2024), Europe (May 2024) and Australia (August 2024) and, in December 2024, they were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).
Earlier this month, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s second Prolia® biosimilar, Rolcya®. Sandoz has previously reported that it expects to launch Jubbonti® and Wyost® in Europe from November 2025.