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news.Biocon has received a Notice of Compliance from Health Canada for Bosaya (denosumab) and Vevzuo (denosumab), both biosimilars referencing Prolia and Xgeva, respectively.
The approval follows comprehensive data supporting Bosaya and Vevzuo’s similarity. Credit: SmartPhotoLab / Shutterstock.com.
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The approval covers Bosaya in a 60mg/ml prefilled syringe and Vevzuo in a 120mg/1.7ml (70mg/ml) single-dose vial, both for subcutaneous injection.
Denosumab therapies are used to increase bone mass and treat osteoporosis, as well as address bone complications in cancer.
Bosaya is indicated for postmenopausal women with osteoporosis and for bone mass increase in men with osteoporosis at high risk for fracture, and for men with nonmetastatic prostate cancer receiving androgen deprivation therapy.
It is also approved to increase bone mass in women with nonmetastatic breast cancer on adjuvant aromatase inhibitor therapy, as well as in both women and men at high fracture risk due to long-term systemic glucocorticoid therapy.
Vevzuo received approval for reducing the risk of skeletal-related events in patients with multiple myeloma and bone metastases from breast, non-small cell lung, prostate cancers, and other solid tumours.
It is also cleared for use in adults and skeletally mature adolescents with giant cell bone tumour that is unresectable or where surgical resection may cause severe morbidity.
The therapy is also intended for treating hypercalcaemia of malignancy refractory to intravenous bisphosphonate therapy.
Biocon CEO and managing director Shreehas Tambe 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.”
The approval follows a comprehensive analytical, nonclinical, and clinical data package. This data supported the similarity of Bosaya and Vevzuo to their reference products with no clinically meaningful differences in terms of safety, quality or efficacy.
Denosumab is a human monoclonal antibody that targets the receptor activator of nuclear factor kappa-B ligand (RANKL).
In May 2024, Biocon entered an exclusive licence and supply agreement with Handok to commercialise synthetic liraglutide in South Korea.
