On 8 October 2024, Teva Pharmaceuticals announced that the US FDA and European Medicines Agency (EMA) accepted Biologics Licence and Marketing Authorisation Applications, respectively, for its TVB-009P, biosimilar to Amgen’s Prolia® (denosumab). Both applications cover all approved indications of Prolia®, including osteoporosis in postmenopausal women with a high risk of fracture. The approval decisions of the FDA and EMA are expected in the second half of 2025.
Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024. Following the April 2024 resolution of US BPCI litigation, commenced by Amgen against Sandoz in May 2023, Jubbonti® and Wyost® are expected to launch in the US from 31 May 2025. No other denosumab biosimilars are currently approved in the US, although Fresenius Kabi’s BLA for its denosumab biosimilar was accepted by the FDA in May 2024.
Sandoz’s Jubbonti® and Wyost® have also been approved in Europe (May 2024). The EMA has accepted MAAs for denosumab biosimilars of Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024) and Shanghai Henlius Biotech/Organon (HLX14, May 2024).