お知らせ • Apr 23
Biocon Limited Receives Health Canada Approval for Bosaya and Vevzuo Biosimilars to Prolia and Xgeva
Biocon Limited announced that Health Canada has granted a Notice of Compliance (NOC) for Bosaya (denosumab), a biosimilar to Prolia, and Vevzuo (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. 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. 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. Warnings and Precautions for BOSAYA include: Hypocalcemia: must be corrected by adequate intake of calcium and vitamin D prior to initiating therapy with BOSAYA. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should be treated. The safety and efficacy of denosumab have not been studied in patients with hepatic impairment. Hypersensitivity: Clinically significant hypersensitivity reactions including anaphylaxis have been reported with denosumab. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. Infections: in women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported for the following: skin infections leading to hospitalization predominantly cellulitis; infections of the abdomen, urinary tract, and ear; endocarditis. Monitoring of calcium is recommended before each dose. Osteonecrosis of the jaw (ONJ) may increase with duration of exposure to BOSAYA. Atypical femoral fractures have been reported in patients receiving denosumab. Multiple vertebral fractures (MVF) may occur following discontinuation of treatment with BOSAYA, particularly in patients with a history of vertebral fracture. Treatment with denosumab resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. Skin: Women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate in the denosumab. BOSAYA is not indicated for use in pediatric patients. There have been no studies of denosumab in pregnant women. BOSAYA is not recommended for use in nursing women. Warnings and Precautions for VEVZUO include: Hypocalcemia: VEVZUO can cause severe symptomatic hypocalcemia and fatal cases. Signs and symptoms of severe hypocalcemia may include, for example, altered mental status, tetany, seizures and QTc prolongation. Hypercalcemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons. No clinical studies have been conducted to evaluate the effect of hepatic impairment. Clinically significant hypersensitivity reactions including anaphylaxis have been reported with denosumab. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. Monitor calcium levels, (i) prior to the initial dose of VEVZUO, (ii) within two weeks after the initial dose, and (iii) if suspected symptoms of hypocalcemia occur. Additional monitoring should be considered during therapy in patients with risk factors for hypocalcemia. ONJ has been reported in patients treated with denosumab or bisphosphonates, another class of anti-resorptive agents. Atypical femoral fracture has been reported with denosumab. Multiple vertebral fractures (MVF), not due to bone metastases, may occur following discontinuation of treatment with VEVZUO, particularly in patients with risk factors such as osteoporosis or prior fractures. There was a greater risk of developing hypocalcemia with increasing degree of renal impairment, and in the absence of, or inadequate calcium supplementation. An imbalance of skin infections leading to hospitalization was reported, predominantly cellulitis. The safety and efficacy of VEVZUO in pregnant women have not been established. It is not known whether VEVZUO is excreted into human milk. 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.
