On 31 October 2025, Accord’s denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®, were approved by Australia’s Therapeutic Goods Administration (TGA) as follows:
- DENOLIA (450306) and DESKELTIA (450307) – denosumab 60mg/1mL solution for injection prefilled syringe with automatic needle guard;
- DOSTIVA (450305) and DEXEVA (450308) – denosumab 70mg/mL (120mg/1.7mL) solution for injection vial.
Accord is the fourth sponsor to obtain approval of denosumab biosimilars in Australia, following Sandoz’s Jubbonti® and Wyost® (August 2024), Celltrion’s Stoboclo® and Osenvelt® (April 2025), and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).
On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed. At its November 2025 meeting, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, for PBS-listing for all reference indications.
In April 2025, Amgen commenced Court proceedings in Australia seeking preliminary discovery of documents from Sandoz in relation to its denosumab biosimilars. That proceeding concluded and Amgen commenced patent infringement litigation against Sandoz in the Federal Court of Australia in June 2025.