Biocon’s arm receives marketing authorisation for Vevzuo and Evfraxy in EU

03 Jul 2025 Evaluate

Biocon’s subsidiary -- Biocon Biologics (BBL) has been granted marketing authorisation by European Commission (EC) in the European Union (EU) for Vevzuo and Evfraxy biosimilars of Denosumab. Vevzuo is authorised for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour (GCT) of bone. Evfraxy is authorised for the treatment of osteoporosis in men and postmenopausal women, the treatment of bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures or treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults. 

Clinical data showed that both Denosumab biosimilars have comparable quality, safety, and efficacy to the reference product. The marketing authorisation follows a positive opinion issued by the European Medicines Agency’s Committee for medicinal products for human use (CHMP) on April 25, 2025.

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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