Biocon gets MHRA UK approval for marketing Denosumab biosimilars 'Vevzuo' & 'Evfraxy'
Vevzuo is authorized for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Vevzuo is also authorized for the treatment of 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.
Evfraxy is authorized for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women this significantly reduces the risk of vertebral, non-vertebral, and hip fractures.
Furthermore, Evfraxy is authorized for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, this significantly reduces the risk of vertebral fractures.
Evfraxy is also authorized for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
Clinical data showed that both Denosumab biosimilars have comparable safety and efficacy to the reference product.
In Europe, the European Commission (EC) recently granted marketing authorisation for Biocon Biologics Denosumab biosimilars, allowing their commercialization in all European Union (EU) member states and the European Economic Area (EEA).
Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions like diabetes, cancer, and autoimmune diseases.
The companys consolidated net profit surged 154.2% to Rs 344.50 crore on a 12.8% jump in net sales to Rs 4,358.10 crore in Q4 FY25 over Q4 FY24.
The scrip fell 1.29% to currently trade at Rs 375.25 on the BSE.
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