Biocon Ltd said on Monday that its arm Biocon Biologics Ltd has received marketing authorisations from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for Vevzuo and Evfraxy, biosimilars of Denosumab used in the treatment of bone-related diseases.
Vevzuo is authorised for preventing of skeletal-related complications like pathological fracture, radiation to bone, spinal cord compression or surgery to bone, in adults with advanced malignancies involving bone, Biocon said in a regulatory filing on Monday. The biosimilar is also authorised 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, on the other hand, is authorised for the treatment of osteoporosis in postmenopausal women and in men who are at increased risk of fractures. In postmenopausal women, this significantly reduces the risk of vertebral, non-vertebral and hip fractures, the company said. Evfraxy is also authorised for the treatment of bone loss associated with hormone ablation in men with prostate cancer who are at increased risk of fractures.
The company said the European Commission (EC) had recently granted marketing authorisation to Biocon Biologics for Denosumab biosimilars by allowing their commercialisation in all European Union member states and the European Economic Area (EEA).
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