Biocon Biologics receives EMA Committee positive opinions for Biosimilar Denosumab for bone health
Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the approval of its denosumab biosimilars candidates for distinct therapeutic indications for bone health: Vevzuo and Denosumab BBL (brand name is currently under approval).
"The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics Ltd," the Company Spokesperson said in a statement.
These recommendations follow a review of comprehensive data packages, including clinical studies results, which demonstrated comparability with the reference product in terms of pharmacokinetic, safety, efficacy and immunogenicity profiles.
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