Sandoz Reports the EMA Acceptance of MAA for Proposed Biosimilar Denosumab

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Sandoz Reports the EMA Acceptance of MAA for Proposed Biosimilar Denosumab


  • 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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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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