Biocon Limited has informed the Exchange regarding a press release dated April 21, 2026, titled "Biocon Receives Health Canada Approval of Bosaya (Denosumab) and Vevzuo (Denosumab), Biosimilars to Prolia® and Xgeva®".
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Biocon Limited has received Health Canada approval for two denosumab biosimilars - Bosaya™ (to Prolia®) and Vevzuo™ (to Xgeva®). The regulatory approval was granted on April 3, 2026. Bosaya is approved as a 60 mg/mL subcutaneous injection in a prefilled syringe, while Vevzuo is approved as a 120 mg/1.7 mL injection in a single-dose vial. These biosimilars address osteoporosis in over 2 million adults and bone metastasis complications in cancer patients. The approval was based on comprehensive analytical, nonclinical, and clinical data demonstrating no clinically meaningful differences from the reference products.
This regulatory milestone expands Biocon's biosimilar portfolio in the Canadian market, potentially benefiting millions of osteoporosis and cancer patients with bone conditions. The approval reinforces the company's global regulatory capabilities and commitment to affordable biologic therapies in immunology and oncology.