Biocon Ltd. on Monday, July 7, said its subsidiary Biocon Biologics Ltd has secured marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA), UK, for its Denosumab biosimilars — Vevzuo and Evfraxy.Vevzuo has been approved for the prevention of skeletal-related events such as pathological fractures, spinal cord compression and the need for radiation or surgery to the bone in adults with advanced malignancies involving bone, Biocon said in an exchange filing.
It is also indicated for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgery may cause significant morbidity.
Evfraxy has been authorised for the treatment of osteoporosis in post-menopausal women and men at increased risk of fractures. The approval also covers its use in reducing the risk of vertebral, non-vertebral, and hip fractures in post-menopausal women.
Additionally, Evfraxy is indicated for treating bone loss associated with hormone ablation in men with prostate cancer and with long-term systemic glucocorticoid therapy in adult patients at risk of fractures.Clinical studies have demonstrated that both biosimilars are comparable in safety and efficacy to the reference product, the company stated.
It is also indicated for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgery may cause significant morbidity.
Evfraxy has been authorised for the treatment of osteoporosis in post-menopausal women and men at increased risk of fractures. The approval also covers its use in reducing the risk of vertebral, non-vertebral, and hip fractures in post-menopausal women.
Additionally, Evfraxy is indicated for treating bone loss associated with hormone ablation in men with prostate cancer and with long-term systemic glucocorticoid therapy in adult patients at risk of fractures.Clinical studies have demonstrated that both biosimilars are comparable in safety and efficacy to the reference product, the company stated.
Earlier, the European Commission (EC) granted marketing authorisation for Denosumab biosimilars, allowing their commercialisation across all European Union (EU) member nations and the European Economic Area (EEA).
Clinical data showed that both Denosumab biosimilars have comparable safety and efficacy to the reference product, the company said in a press release.
Shares of Biocon were trading 1,29% lower at ₹375.15 apiece at 10.55 am on Monday, July 7. The stock has gained 10.9% in the past month.
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