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Samsung Bioepis FDA Approval BPCIA

Goodwin

Denosumab Updates: Wyost and Jubbonti Launch as First Denosumab Biosimilars in the U.S.

Goodwin on

On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. ...more

Venable LLP

FDA Approves Second Prolia® / Xgeva® (denosumab) Interchangeable Biosimilars: Samsung Bioepis’s Ospomyv™ / Xbryk™

Venable LLP on

On February 13, 2025, the FDA approved Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb) as the second interchangeable biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more

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