Jubereq Receives Positive CHMP Opinion
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Jubereq, intended for the prevention of skeletal-related events in adults with advanced malignancies involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone
The applicant for this medicinal product is Accord Healthcare S.L.U. Jubereq is a biosimilar product. It is highly similar to the reference product Xgeva (denosumab), which was authorised in the EU on 13 July 2011. Data show that Jubereq has comparable quality, safety and efficacy to Xgeva (denosumab).
The full indication is:
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.
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.
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