CHMP positive for Obodence ((denosumab biosimilar) to treat osteoporosis

Obodence has been recommended for approval for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. 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.

“In Europe alone, approximately 22.1% of women and 6.6% of men are affected by osteoporosis. Osteoporosis and cancer-related bone loss can lead to skeletal fractures, seriously affecting the quality of life of patients. Enhancing access to treatment options is essential for improving both patient outcomes and quality of life (QoL) as it allows timely treatment for patients,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “If approved, Obodence/Xbryk would become our first endocrinology biosimilar, 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.  In addition, a randomized, double-blind, multi-center Phase III study demonstrated equivalent efficacy and comparable safety, immunogenicity, PK, and pharmacodynamics (PD) profiles between SB16 and reference denosumab (DEN) in postmenopausal osteoporosis (PMO) patients. The primary endpoint was met in terms of percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 12, and a follow-up up to Month 18 demonstrated switching to SB16 from DEN were comparable up to Month 18 in terms of efficacy, PK, PD, safety and immunogenicity.

The CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide whether to grant marketing authorizations for Obodence and Xbryk. If a marketing authorization is granted by the EC, OBODENCE and XBRYK would become Samsung Bioepis’ first endocrinology biosimilar approved in Europe, further expanding the company’s biosimilars portfolio.