Biocon Ltd on Tuesday said it has received a notice of compliance from Health Canada for its biosimilars Bosaya and Vevzuo, indicated for the treatment of osteoporosis and bone complications associated with cancer.
Health Canada has granted a notice of compliance (NOC) for Bosaya (denosumab), a biosimilar to Prolia, and Vevzuo (denosumab), a biosimilar to Xgeva, on April 3, 2026, Biocon Ltd said in a regulatory filing.
“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,” it said.
Commenting on the development, Biocon Ltd CEO & Managing Director, Shreehas Tambe, said, “Health Canada’s approval of Bosaya and Vevzuo marks another important milestone for Biocon as we continue to expand access to high-quality biosimilars in key global markets.” He further said, “This approval reflects our strong scientific and regulatory capabilities and reinforces our commitment to patients living with osteoporosis and cancer-related bone conditions, while further strengthening our portfolio of affordable biologic therapies across immunology and oncology.” Biocon said 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 by Health Canada 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, the company said.