Celltrion secures EU approval for 2 osteoporosis biosimilar drugs

Celltrion announced on Tuesday that it received European Commission (EC) approval for Stoboclo and Osenvelt, its biosimilars referencing Prolia and Xgeva (denosumab).

Prolia and Xgeva share the same active ingredient, with Prolia approved for osteoporosis treatment and Xgeva for preventing skeletal-related complications in cancer patients with bone metastases. Stoboclo has been approved for postmenopausal osteoporosis and bone loss treatment, while Osenvelt is indicated for preventing bone metastasis complications in cancer patients and treating giant cell tumors of the bone, mirroring the indications of their reference biologics.

Both biosimilars were also approved in South Korea in November 2024 and recently completed regulatory filings in the United States, all indicative of the company’s smooth progress in key global markets.

The combined global sales of Prolia and Xgeva totaled around 9 trillion won ($6.24 billion) in 2024. With its latest EU approval, Celltrion aims to accelerate market expansion domestically and internationally.

This is Celltrion’s third major regulatory approval in February 2025, following the previous week’s EC approval of Eydenzelt, the company’s biosimilar for Eylea.