Biocon Biologics receives EU approval for denosumab biosimilars

Biocon Biologics Ltd. announced that the European Commission (EC) has approved its Denosumab biosimilars, Vevzuo and Evfraxy, for use in the European Union. Vevzuo is authorized for preventing bone complications in adults with advanced cancer involving bone and treating adults and adolescents with giant cell tumor of bone. Evfraxy is approved for treating osteoporosis in men and postmenopausal women, as well as bone loss associated with hormone ablation in men with prostate cancer or long-term glucocorticoid therapy. The approvals are based on clinical data demonstrating comparable quality, safety, and efficacy to the reference product. This milestone marks the company's rapid expansion and support for healthcare systems in the region.