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 access to advanced biologic therapies in Canada. The approval, granted on April 3, 2026, covers BOSAYA™ as a biosimilar to Prolia and VEVZUO™ as a biosimilar to Xgeva.
Both products are approved in widely used formulations, with BOSAYA™ available as a 60 mg/mL prefilled syringe for subcutaneous injection, and VEVZUO™ as a 120 mg/1.7 mL single-dose vial. Denosumab therapies are widely used to support bone health by increasing bone mass, treating osteoporosis, and managing bone-related complications associated with cancer.
BOSAYA™ has been approved for multiple indications, including treatment of osteoporosis in postmenopausal women and men at high risk of fractures, as well as for patients undergoing hormone-related therapies for breast and prostate cancer. It is also indicated for individuals at risk of bone loss due to long-term glucocorticoid therapy.
VEVZUO™ is approved for reducing skeletal-related events in patients with multiple myeloma and bone metastases from various cancers, including breast, prostate, and lung cancers. It is also indicated for treating giant cell tumour of bone in eligible patients and for managing hypercalcemia of malignancy that does not respond to standard treatments.
The approvals are supported by extensive analytical, nonclinical, and clinical data demonstrating that both biosimilars are highly comparable to their reference products in terms of quality, safety, and efficacy, with no clinically meaningful differences.
Denosumab is a monoclonal antibody that targets RANKL, a key regulator of bone resorption. By inhibiting RANKL, it reduces bone breakdown and improves bone strength, playing a critical role in managing chronic bone-related conditions.
Shreehas Tambe, CEO and Managing Director of Biocon Limited, stated that the approval represents a key milestone in the company’s global biosimilars strategy. He noted that it reinforces Biocon’s commitment to expanding access to high-quality, affordable biologic therapies for patients dealing with osteoporosis and cancer-related bone diseases, while strengthening its presence in international markets.
Headquartered in Bengaluru, Biocon Limited is a global biopharmaceutical company focused on delivering affordable, innovative therapies across areas such as diabetes, oncology, cardiovascular diseases, immunology, and bone health. The company operates in over 120 countries, supported by a strong pipeline of biosimilars and generics, integrated manufacturing capabilities, and a robust research and development network.
