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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 reference
  • Denosumab is a mAb that works by targeting RANKL which regulates bone metabolism & osteoclast formation

Ref: PRNewswire | Image: Biocon Biologics

Related News:- The US FDA Approves Biocon Biologics’ Jobevne (Biosimilar, Avastin)

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