Biocon Secures Health Canada Nod for Denosumab Biosimilars Bosaya, Vevzuo
Bengaluru: Biocon Limited has received a Notice of Compliance (NOC) from Health Canada for its denosumab biosimilars Bosaya and Vevzuo, marking a significant step in expanding its global biosimilars footprint.
The approval, granted on April 3, 2026, covers Bosaya, a biosimilar to Prolia, and Vevzuo, a biosimilar to Xgeva. Both products have been cleared in their commonly used presentations—Bosaya as a 60 mg/mL prefilled syringe for subcutaneous injection, and Vevzuo as a 120 mg/1.7 mL single-dose vial for subcutaneous use.
Denosumab, a monoclonal antibody targeting RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), plays a crucial role in bone health by inhibiting osteoclast-mediated bone resorption. It is widely used in the management of osteoporosis as well as bone-related complications arising from cancers.
Commenting on the development, Shreehas Tambe, CEO and Managing Director of Biocon Ltd., 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. 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.”
Bosaya has been approved for multiple indications, including treatment of osteoporosis in postmenopausal women and men at high fracture risk, and for increasing bone mass in patients undergoing hormone-related therapies for breast and prostate cancers, as well as those on long-term glucocorticoid treatment.
Vevzuo, on the other hand, is indicated for reducing the risk of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, treatment of giant cell tumour of bone, and management of hypercalcemia of malignancy that is refractory to bisphosphonate therapy.
The approval is supported by a comprehensive package of analytical, non-clinical, and clinical data demonstrating that both biosimilars are highly similar to their reference products, with no clinically meaningful differences in quality, safety, or efficacy.
With this approval, Biocon continues to strengthen its presence in global regulated markets, particularly in the biosimilars segment, where it is focused on addressing unmet medical needs in areas such as oncology and bone health.
