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 deal with Bio-Thera to enable Accord BioPharma to bring the Simponi biosimilar BAT2506 to the US
Ref: PRNewsWire | Image: Accord BioPharma | Press Release
Related News:- Accord BioPharma launches Imuldosa (Biosimilar, Stelara) PFS at the lowest WAC
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