Biocon Limited has achieved a significant milestone with Health Canada granting approval for its biosimilar products, Bosaya™ and Vevzuo™. These denosumab-based biosimilars are equivalent to Prolia® and Xgeva® and were approved on April 3, 2026. Bosaya is available as a 60 mg/mL injection for subcutaneous use in a prefilled syringe, while Vevzuo is offered as a 120 mg/1.7 mL injection for subcutaneous use in a single-dose vial.
Denosumab products are crucial in enhancing bone health by increasing bone mass and treating osteoporosis, as well as addressing bone complications associated with cancer. The approval by Health Canada is expected to benefit over 2 million adults with osteoporosis and numerous patients with bone metastasis annually.
Shreehas Tambe, CEO & Managing Director of Biocon Ltd., expressed that this approval is a testament to Biocon’s scientific and regulatory capabilities. It reinforces the company’s commitment to providing high-quality biosimilars to patients dealing with osteoporosis and cancer-related bone conditions.
Bosaya is approved for treating postmenopausal women and men with osteoporosis at high risk for fracture, men with nonmetastatic prostate cancer receiving androgen deprivation therapy, and women with nonmetastatic breast cancer on adjuvant aromatase inhibitor therapy. It is also approved for individuals at high risk for fracture due to long-term glucocorticoid therapy.
Vevzuo is approved for reducing the risk of skeletal-related events in patients with multiple myeloma and bone metastases from various cancers. It is also indicated for treating hypercalcemia of malignancy that is refractory to intravenous bisphosphonate.
The approval is based on comprehensive 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.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).