On 13 February 2025, the US FDA approved Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb, SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively. The biosimilars are approved for the same indications as the reference medicines.
Ospomyv™ and Xbryk™ are the second denosumab biosimilars to be approved in the US, following the approval of Sandoz’s Wyost® and Jubbonti® in March 2024.
There are also a number of denosumab biosimilars in the wings, with the FDA having accepted applications for review, including for: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024). In December 2023, Celltrion filed an abbreviated Biologics Licence Application (aBLA) for its denosumab biosimilar, CT-P41. Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).
In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars. That litigation remains pending, as do similar proceedings brought by Amgen against Fresenius Kabi (FKS518/commenced October 2024) and Accord/Intas (INTP23/commenced November 2024). A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances). Amgen also settled its US litigation against Celltrion in January 2025, permitting launch of Celltrion’s yet to be US-approved denosumab biosimilar from 1 June 2025.
Samsung Bioepis received a positive opinion from the European Medicine Agency’s CHMP in November 2024 for its denosumab biosimilars (to be marketed as Obodence™ and Xbryk™ in Europe).