On 4 April 2025, Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration (TGA). Celltrion is the second sponsor to achieve approval of its denosumab biosimilars in Australia, following approval of Sandoz’s Jubbonti® and Wyost® in August 2024.
In December 2024, Sandoz’s denosumab biosimilars were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS). In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia.
In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.