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  • Samsung Bioepis¡¯ Xgeva biosimilar approved in KOR
  • by Chon, Seung-Hyun | translator Alice Kang | Jun 2, 2025 05:50am
Xbryk approved by the MFDS¡¦two denosumab biosimilars all approved in Korea

Samsung Bioepis announced on the 30th that it has received approval from the Ministry of Food and Drug Safety for its biosimilar Xbryk, a bone disease treatment.

Xbryk, which contains denosumab, is used to prevent skeletal complications in cancer patients and treat tumor diseases such as giant cell tumor of bone. Prolia, which contains the same ingredient, has been approved as a treatment for endocrine disorders such as postmenopausal osteoporosis.

Last year, the combined global sales of Prolia and Xgeva reached USD 6.599 billion (approximately KRW 10 trillion). The domestic market prescription volume amounted to approximately KRW 187 billion.

Samsung Bioepis has pursued separate product approvals for each
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