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Approval Alert: Celltrion’s Denosumab Biosimilars Third to be Approved in Europe

Feb 19, 2025

On 19 February 2025, Celltrion announced that the European Commission has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.

Celltrion’s denosumab biosimilars are the third to be approved in Europe, following approval of Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).

Stoboclo® and Osenvelt® received positive opinions from the EMA’s CHMP in December 2024.

The EMA 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).

Celltrion filed an abbreviated Biologics Licence Application for CT-P41 in the US in December 2023.  However, in May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation was settled in January 2025, allowing Celltrion to launch its denosumab biosimilars in the US from 1 June 2025.