Shots:
Accord Healthcare has launched Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab), following patent expiry of reference products on Nov 27, 2025
Osvyrti (60mg PFS) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It is also used to treat bone loss in pts on…
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…
Shots:
The CHMP has recommended Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab); launch expected post patent expiry of reference products in Nov 2025
Osvyrti (60mg pre-filled syringe) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It also used to treat bone loss in pts…

