Celltrion's bone disease biosimilars get approval in U.S.
Published: 04 Mar. 2025, 16:28
Logo of Celltrion
Celltrion, a major Korean biopharmaceutical firm, said Tuesday that its two new biosimilars for bone disease treatment have obtained approval from the United States.
The U.S. Food and Drug Administration (FDA) approved Celltrion's Stoboclo and Osenvelt, biosimilar drugs to Prolia and Xgeva, respectively, in the form of subcutaneous formulations for sale in the U.S. market, the company said in a press release.
The global market for Prolia and Xgeva was estimated to have reached a combined 9.2 trillion won ($6.6 billion) last year, it said.
The U.S. accounted for 6.15 trillion won, or 67 percent, of the two original drugs' sales last year.
Last month, Celltrion obtained FDA approval to sell Avtozma, an autoimmune disease biosimilar to Actemra, in both intravenous and subcutaneous formulations in the country.
The Korean drugmaker aims to commercialize 22 biosimilar products by 2030, up from the current 11.
Yonhap
with the Korea JoongAng Daily
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