On 16 February 2025, Samsung Bioepis announced that the European Commission has approved Obodence™ (60mg pre-filled syringe) and Xbryk™ (120mg vial), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. The biosimilars are approved for the same indications as the reference medicines.
This announcement came just days after the FDA approval of Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb) on 13 February 2025.
Obodence™ and Xbryk™ received positive CHMP opinions in November 2024, and are the second set of denosumab biosimilars to be approved in the EU, following Sandoz’s Wyost® and Jubbonti® (approved May 2024).
The European Medicines Agency has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024). The CHMP adopted positive opinions for Celltrion’s Osenvelt®/CT-P41 and Stoboclo®/CT-P41 in December 2024.