Biocon Biologics receives EU marketing authorisation for Vevzuo and Evfraxy biosimilars of Denosumab

Biocon Biologics(BBL), a fully integrated global biosimilars company and subsidiary of Biocon, today announced that the European Commission (EC) has granted marketing authorisation 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 25 April 2025.

Powered by Capital Market - Live News