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