CHMP positive for Xbryk (denosumab biosimilar) for for the prevention of skeletal related events and giant tumour of the bone

Xbryk  has been recommended for approval for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and 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.

 If approved, Obodence/Xbryk would become the r first endocrinology biosimilar for the company, adding to our growing portfolio of biosimilar products that are helping to improve patient’s quality of life and access to treatments, and relieve the financial burden of healthcare systems. 

The CHMP’s positive opinion was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-blind, three-arm, parallel group, single-dose Phase 1 study demonstrated the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced denosumab (US-DEN) in healthy male participants. The primary PK endpoints were met, in terms of area under the concentration-time curve (AUC) from time zero to infinity, and maximum serum concentration.