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Sandoz Reports the US FDA Acceptance of BLA for Proposed Biosimilar Denosumab

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Sandoz Reports the US FDA Acceptance of BLA for Proposed Biosimilar Denosumab

Shots:

  • The US FDA has accepted the BLA for a proposed biosimilar denosumab (Prolia and Xgeva) for various conditions incl. osteoporosis in postmenopausal women and men with high fractures risk, treatment-induced bone loss
  • The submission was based on the comprehensive analytical and clinical data package, incl. the P-I/III trial (ROSALIA) which showed a similarity b/w Sandoz’s denosumab and the reference medicine in postmenopausal osteoporosis women in terms of safety, immunogenicity, PD, efficacy & PK
  • The company continues to build a biosimilars portfolio to increase patient access to high-quality therapies and support healthcare system sustainability

Ref: Novartis | Image: Sandoz

Related News:- HK inno.N Entered into an Exclusive License Agreement with mAbxience for Denosumab Biosimilar to Treat Bone Disease

Click here to­ read the full press release 

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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