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Bengaluru-based Biocon Biologics Ltd (BBL), the biosimilars company and subsidiary of Biocon Ltd, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions on its denosumab biosimilars - Vevzuo and Denosumab BBL- recommending its approval for distinct therapeutic indications for bone health
These recommendations were submitted after a review of comprehensive data packages and clinical studies results demonstrating comparability with the reference product in terms of pharmacokinetic, safety, efficacy and immunogenicity profiles.
Following a review of the CHMP recommendations by European Commission, approved indications and usage will be included into the Summary of Product Characteristics (SmPCs), and the European Public Assessment Reports (EPARs)
(With inputs from BL Intern Rohan Das)
Published on April 26, 2025
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