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  • Samsung Bioepis¡¯s Prolia and Xgeva biosimilars approved
  • by Chon, Seung-Hyun | translator Alice Kang | Feb 18, 2025 05:53am
in the US and Europe
Both products approved in the US and Europe... enter the KRW 10 trillion market
 ¡ã Pic of Samsung Bioepis Headquarters

Samsung Bioepis' two bone disease treatment biosimilars have passed the US and European hurdles.

Samsung Bioepis announced on the 16th that it has obtained marketing authorizations for its two biosimilar versions of Prolia and Xgeva, which are bone disease treatments, from the US Food and Drug Administration (FDA) and the European Commission (EC).

Prolia and Xgiva are biopharmaceuticals developed by Amgen, and the two were developed by varying the dose and dosage cycle of the main ingredient, denosumab. Prolia is used as a treatment for osteoporosis, and Xgeva is approved for the prevention of skeletal system symptoms in patients with bone metastases and the treatment of giant cell tumors of bone.

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