Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon, 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 related to bone health: Vevzuo and Denosumab BBL. The brand name Denosumab BBL 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. These recommendations follow a review of comprehensive data packages, including clinical study results, which demonstrated comparability with the reference product in terms of pharmacokinetic, safety, efficacy, and immunogenicity profiles.
The European Commission will now review the CHMP opinions. Following its decision, detailed information on the approved indications and usage will be incorporated into the Summary of Product Characteristics (SmPCs) and the European Public Assessment Reports (EPARs), which will be 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