Biocon Receives Health Canada Approval of Bosaya™ and Vevzuo™, Biosimilars to Prolia® and Xgeva®

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:

- of postmenopausal women with osteoporosis at high risk for fracture
- to increase bone mass in men with osteoporosis at high risk for fracture
- to increase bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT), who are at high risk for fracture

- to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor (AI) therapy

- to increase bone mass in women and men at high risk for fracture due to sustained systemic glucocorticoid therapy and fracture who are starting or have recently started long term glucocorticoid therapy

VEVZUO is approved for the treatment of:

- reducing the risk of developing skeletal-related events in patients with multiple myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours

- adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity

treatment of hypercalcemia of malignancy that is refractory to intravenous bisphosphonate.

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.

Shares of Biocon Limited was last trading in BSE at Rs. 358.50 as compared to the previous close of Rs. 358.20. The total number of shares traded during the day was 123511 in over 3762 trades.

The stock hit an intraday high of Rs. 362.50 and intraday low of 355.00. The net turnover during the day was Rs. 44391419.00.

Source : Equity Bulls

Keywords

Biocon INE376G01013 Biotechnology HealthCanada Approval NOC denosumab Biosimilars