Biocon’s Bosaya (denosumab), a biosimilar to Prolia, and Vevzuo (denosumab), a biosimilar to Xgeva, have received Notice of Compliance (NOC) from Health Canada. Both biosimilars were approved in the most common presentations: BOSAYA, as a 60 mg/mL injection for subcutaneous use in a prefilled syringe; and VEVZUO, as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial.
Denosumab products play a key role in bone health by increasing bone mass and treating osteoporosis, as well as bone complications associated with cancer.
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data, demonstrating that BOSAYA and VEVZUO are highly similar to PROLIA and XGEVA, respectively, with no clinically meaningful differences in quality, safety, or efficacy.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.
