Degevma

<p>On 18 September 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Degevma, 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.</p><p>The applicant for this medicinal product is TEVA GmbH.</p><p>Degevma will be available as a 120 mg solution for injection. The active substance of Degevma is denosumab, a drug for the 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 plays a key role in bone destruction in patients with advanced cancer of bones. 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 in cortical and trabecular bones.</p><p>Degevma 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 Degevma has comparable quality, safety and efficacy to Xgeva.</p><p>The full indication is:</p><p>Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).</p><p>Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.</p><p>Degevma should be administered under the responsibility of a healthcare professional.</p><p>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.</p>