On 1 September 2025, Australia’s Pharmaceutical Benefits Scheme published its summary of changes for the month of September. Among the changes was the PBS-listing of Amgen’s supplemental denosumab brands, Corora® (60mg/ml PFS) and Ganvado® (70mg/ml vial), referencing Prolia® and Xgeva®, respectively.
The additional brands are two of the five Amgen brands of denosumab approved by Australia’s TGA in November 2024 (Ganvado™, Zerount™, Corora™, Rexadev™ and Deptargis™). In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.
The PBS-listing of Amgen’s supplemental denosumab brands comes amidst the commencement of biosimilar competition in Australia. On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed. Jubbonti® and Wyost® were also the first denosumab biosimilars to be approved in Australia (August 2024), followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).
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.