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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 2025Approval was based on the comprehensive clinical data, which showed comparable PK, safety, efficacy & immunogenicity of Vevzuo & Evfraxy to the reference productVevzuo prevents SREs in adults with bone-involved malignancies…
July 4, 2025

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Biocon Biologics Receives CHMP’s Positive Opinion for Vevzuo and Denosumab BBL (Biosimilars, Xgeva and Prolia)

Shots:The CHMP has recommended Vevzuo & Denosumab BBL (brand name under approval), biosimilars of Xgeva & Prolia (denosumab)Opinion was based on the comprehensive clinical data submitted by Biosimilar Collaborations Ireland (Biocon Biologics’ subsidiary) incl. trials, which showed comparable PK, safety, efficacy & immunogenicity to the referenceDenosumab is a mAb that works by targeting…
April 29, 2025

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