Biocon Biologics Receives Positive CHMP Opinions for Biosimilar Denosumab in Europe

Biocon Biologics Ltd (BBL), 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, Vevzuo® and Denosumab BBL, for distinct therapeutic indications for bone health. The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics Ltd. 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. The European Commission will review the CHMP opinions and, following its decision, detailed information on the approved indications and usage will be included into the Summary of Product Characteristics (SmPCs), and the European Public Assessment Reports (EPARs), available in all official European Union languages. Until marketing authorisations are granted by the European Commission, these products are not approved for use in the European Union.