CHMP positive for Osenvelt (denosumab biosimilar)
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Osenvelt (denosumab biosimilar), intended for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone
The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.
Osenvelt will be available as 120 mg solution for injection. The active substance of Osenvelt is denosumab, a drug for treatment of bone diseases (ATC code: M05BX04). Denosumab is a human monoclonal IgG2 antibody that targets the protein RANKL, which is essential for the formation, function and survival of osteoclasts, the cell type responsible for bone resorption. Increased osteoclast activity stimulated by RANKL is a key mediator of bone destruction in metastatic bone disease. Denosumab binds to RANKL with high affinity and specificity, preventing the interaction between RANKL and RANK. This leads to a reduction in osteoclast numbers and function, and a decrease in bone resorption and cancer-induced bone destruction.
Osenvelt 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 Osenvelt has comparable quality, safety and efficacy to Xgeva (denosumab).
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