Biocon denosumab approved
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for recommending the granting of a marketing authorisation for the medicinal product Vevzuo, intended for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for recommending the granting of a marketing authorisation for the medicinal product Vevzuo, intended for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
The applicant is Biosimilar Collaborations Ireland Limited, a Biocon Biologics subsidiary company. Vevzuo is a biosimilar medicinal product. It is highly similar to the reference product Xgeva (denosumab), which was authorised in the EU on 13 July 2011. Data show that Vevzuo has comparable quality, safety and efficacy to Xgeva.
Vevzuo will be available as a 120 mg solution for injection. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
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