Celltrion logo (Celltrion)

South Korean biosimilar giant Celltrion announced Friday that its biosimilars, Stoboclo and Osenvelt, have been approved by the Ministry of Food and Drug Safety.

The two biosimilars, referencing Amgen’s Prolia and Xgeva, respectively, are the first denosumab biosimilars to be approved in Korea.

Prolia is used to treat osteoporosis in postmenopausal women and increase bone density in men, while Xgeva is prescribed to prevent skeletal-related complications in cancer patients with bone metastases.

According to Celltrion, Stoboclo and Osenvelt have been approved for all indications of their reference drugs. These include Prolia’s treatment for osteoporosis and Xgeva’s prevention of bone-related conditions in cancer patients.

Applications for regulatory approval have also been submitted in the US and Europe, where Celltrion aims to enter the global denosumab market, valued at 8 trillion won ($6.16 billion) as of last year.

The company said the domestic approval of Stoboclo and Osenvelt strengthens its position as a “first mover” in the biosimilars market and enhances its competitive edge. Celltrion also plans to expand its portfolio into new treatment areas such as bone and eye diseases while preparing for the domestic and international launch of the two biosimilars.

“By securing domestic approval for Stoboclo and Osenvelt, we can now provide Korean patients with more affordable treatment options while maintaining the same efficacy as existing therapies,” a Celltrion official said. “We will accelerate our efforts to obtain regulatory approvals in key overseas markets, including the US and Europe, to expand access for patients globally.”

By Park Li-na (linapark@heraldcorp.com)