Seoul: Celltrion Inc., a major South Korean biopharmaceutical firm, announced that its two new biosimilars for bone disease treatment have obtained approval from the United States.
According to Yonhap News Agency, the U.S. Food and Drug Administration (FDA) approved Celltrion's Stoboclo and Osenvelt, which are biosimilar drugs to Prolia and Xgeva, respectively. These approvals are for subcutaneous formulations for sales in the U.S. market, as stated by the company in a press release.
The global market for Prolia and Xgeva was estimated to have reached a combined 9.2 trillion won (US$6.6 billion) last year. The U.S. accounted for 6.15 trillion won, or 67 percent, of the two original drugs' sales last year.
Last month, Celltrion received FDA approval for the U.S. sale of Avtozma, an autoimmune disease biosimilar to Actemra, available in both intravenous and subcutaneous formulations. The Korean drugmaker aims to commercialize 22 biosimilar products by 2030, up from the current 11.