Sandoz Reports the EMA Acceptance of MAA for Proposed Biosimilar Denosumab
Shots:
- The EMA has accepted the MAA for the proposed biosimilar denosumab (Prolia & Xgeva) indicated for treating multiple indications incl. osteoporosis in postmenopausal women, men with high fractures risk & treatment-induced bone loss
- The application was based on comprehensive analytical & clinical data incl. data from a P-I PK/PD similarity study in healthy volunteers and the P-I/III study (ROSALIA) study which showed a similarity b/w denosumab & reference medicine in terms of PK, PD, efficacy, safety & immunogenicity in the respective study populations
- The company continues to build a biosimilars portfolio to increase patient access to high-quality, affordable biologics & generate savings for healthcare systems
Ref: Sandoz | Image: Sandoz
Related News:- Mabwell’s Mailishu (biosimilar, denosumab) Receives the NMPA’s Approval for the Treatment of Osteoporosis in China
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