Biocon Biologics Receives the EC’s Approval for Vevzuo and Evfraxy (Biosimilars, Xgeva and Prolia)
Shots:
- The EC has approved Vevzuo & Evfraxy, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP positive opinion in Apr 2025
- Approval was based on the comprehensive clinical data, which showed comparable PK, safety, efficacy & immunogenicity of Vevzuo & Evfraxy to the reference product
- Vevzuo prevents SREs in adults with bone-involved malignancies & treats unresectable or high-morbidity giant cell tumors of bone in adults & skeletally mature adolescents, while Evfraxy treats osteoporosis in postmenopausal women & men at high risk of fracture, & bone loss in pts on long-term glucocorticoids as well as in prostate cancer pts on hormone ablation
Ref: Biocon Biologics | Image: Biocon Biologics| Press Release
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