Biocon Limited announces that Health Canada granted a Notice of Compliance for Bosaya and Vevzuo on April 3, 2026. Both products are denosumab biosimilars to Prolia and Xgeva in approved therapeutic categories. BOSAYA is available as a 60 mg per mL subcutaneous injection in a prefilled syringe. VEVZUO is available as a 120 mg per 1.7 mL subcutaneous injection in a single-dose vial. Denosumab therapies increase bone mass and support the treatment of osteoporosis and cancer-related bone complications.
Shreehas Tambe, CEO & Managing Director, 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.”
Clinical Indications and Supporting Data
BOSAYA treats postmenopausal women with osteoporosis who face a high risk of fractures. It increases bone mass in men with osteoporosis and patients undergoing androgen deprivation therapy for prostate cancer. Additionally, it supports women receiving aromatase inhibitor therapy for breast cancer and glucocorticoid-induced bone loss.
VEVZUO reduces skeletal-related events in multiple myeloma patients and those with bone metastases from solid tumors. It also treats giant cell tumors of bone and hypercalcemia of malignancy resistant to bisphosphonate therapy. The approval relies on extensive analytical, nonclinical, and clinical evidence supporting biosimilar comparability. Studies confirm both products match PROLIA and XGEVA in quality, safety, and therapeutic effectiveness without meaningful differences.
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News Source: Businesswire.com
