Health
Biocon Receives Health Canada Approval of Bosaya™ (Denosumab) and Vevzuo™ (Denosumab), Biosimilars to Prolia® and Xgeva®
TORONTO & BENGALURU, India, April 21, 2026--Biocon Receives Health Canada Approval of Bosaya™ and Vevzuo™ (Denosumab biosimilars to Prolia® and Xgeva®) for bone health.
About this update from Biocon Limited
TORONTO & BENGALURU, India, April 21, 2026--(BUSINESS WIRE)--Biocon Limited (BSE: 532523; NSE: BIOCON), an innovation‑led global biopharmaceutical company, is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for Bosaya™ (denosumab), a biosimilar to Prolia®, and Vezuo™ (denosumab), a biosimilar to Xgeva®, on April 3, 2026. Both biosimilars were approved in the most common presentations: BOSAYA, as a 60 mg/mL injection for subcutaneous use in a prefilled syringe; and VEVZUO, as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial. Denosumab products play a key role in bone health by increasing bone mass and treating osteoporosis, as well as bone complications associated with cancer. 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." BOSAYA is approved for the treatment: VEVZUO is approved for the treatment of: The approval is based on a comprehensive package of analytical, nonclinical, and clinical data, demonstrating that BOSAYA and VEVZUO are highly similar to PROLIA and XGEVA, respectively, with no clinically meaningful differences in quality, safety, or efficacy. About BOSAYA and VEVZUO: Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). RANKL is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, denosumab reduces bone breakdown, increasing bone mass and strength. About BOSAYA (denosumab) Warnings and Precautions: About VEVZUO (denosumab) Warnings and Precautions: Please refer to full Product Monograph for BOSAYA and VEVZUO for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon at 1-833-986-1468. About Biocon Limited Biocon Limited (BSE: 532523, NSE: BIOCON) is a global biopharmaceutical company driven by its purpose to provide affordable, life-c...