Biocon’s arm receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

07 Jul 2025 Evaluate

Biocon’s subsidiary -- Biocon Biologics (BBL) has received marketing authorisations by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for Vevzuo and Evfraxy, biosimilars of Denosumab.

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. 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. 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 India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.


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