Organon and Shanghai Henlius Biotech announced on 30 October 2024 that the FDA accepted their BLA for HLX14, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab). This comes 5 months after the European Medicines Agency (EMA) validated Henlius’ and Organon’s applications for denosumab in May 2024.
Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024. US BPCI litigation commenced by Amgen against Sandoz in May 2023 in relation to denosumab was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances. 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 and Teva’s BLA for TVB-009P (denosumab) was accepted by the FDA in October 2024.
In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.