On 9 July 2025, Samsung Bioepis’ denosumab biosimilars, Ospomyv® and Xborso® (SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration (TGA), for all reference indications.
Samsung Bioepis is the third sponsor to obtain approval of denosumab biosimilars in Australia, following Sandoz’s Jubbonti® and Wyost® in August 2024 and Celltrion’s Stoboclo® and Osenvelt® in April 2025.
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.
Samsung Bioepis’ denosumab biosimilars were approved in Europe and the US in February 2025 (as Obodence™ and Xbryk™). In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars. Those proceedings are ongoing.