Biocon Limited has secured regulatory approval in Canada for two of its denosumab biosimilars, marking a significant expansion of its global biosimilars portfolio. The company announced that Health Canada has granted a Notice of Compliance (NOC) for Bosaya and Vezuo, referencing the originator drugs Prolia and Xgeva, respectively.
The approvals, dated April 3, 2026, allow both products to be marketed in their commonly used formulations. Bosaya will be available as a 60 mg/mL subcutaneous injection in a prefilled syringe, while Vezuo will be supplied as a 120 mg/1.7 mL (70 mg/mL) subcutaneous injection in a single-dose vial. These therapies are designed to address critical needs in bone health, particularly in patients with osteoporosis and cancer-related bone complications.
Denosumab, the active ingredient in both biosimilars, is a monoclonal antibody that plays a crucial role in increasing bone mass and reducing the risk of fractures. It is widely used in managing Osteoporosis and preventing skeletal-related events in patients with cancers that have spread to the bones. By introducing more affordable biosimilar versions, Biocon aims to improve access to these important therapies.
According to Shreehas Tambe, CEO and Managing Director of Biocon, the approval represents a key milestone for the company’s global expansion strategy. He emphasized that the decision underscores Biocon’s scientific and regulatory capabilities, while reinforcing its commitment to delivering cost-effective biologic treatments for patients dealing with chronic and serious conditions. The move also strengthens the company’s footprint in immunology and oncology.
Bosaya has received approval for multiple indications, including treatment of postmenopausal women and men with osteoporosis at high risk of fractures. It is also indicated for patients undergoing hormone-related cancer therapies, such as those with nonmetastatic prostate cancer receiving androgen deprivation therapy and women with breast cancer undergoing aromatase inhibitor treatment. Additionally, it can be used in patients at risk of fractures due to long-term glucocorticoid therapy.
Vezuo, on the other hand, is approved for oncology-related uses. These include reducing the risk of skeletal-related events in patients with multiple myeloma and those with bone metastases from various cancers, including breast, prostate, and lung cancers. It is also indicated for treating giant cell tumor of bone and managing hypercalcemia of malignancy that does not respond to standard treatments.
The approvals are based on a comprehensive data package, including analytical, nonclinical, and clinical studies demonstrating that both biosimilars are highly similar to their reference products, with no clinically meaningful differences in safety, efficacy, or quality.
With this latest development, Biocon continues to strengthen its position in the global biosimilars market, addressing unmet needs in bone health and oncology while supporting broader access to life-saving biologic therapies.