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Accord BioPharma Receive the US FDA’s Approval for Osvyrti and Jubereq (Biosimilar, Prolia and Xgeva)   

Shots:  The US FDA has approved Osvyrti and Jubereq biosimilars to Prolia and Xgeva. Accord is anticipated to commercialize OSVYRTI and JUBEREQ in 2026   The approvals were supported by a P-I study showing JUBEREQ and Xgeva had comparable PK, and a P-III study in postmenopausal women with osteoporosis demonstrating that OSVYRTI and Prolia are highly similar with no clinically meaningful differences in PK, PD, safety, or efficacy  Intas has an exclusive…

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