Biocon Biologics has received marketing authorisation from the European Commission for its denosumab biosimilars, Vevzuo and Evfraxy, following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025.
Denosumab is a fully human monoclonal antibody that targets RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), a key protein involved in osteoclast development and function. By inhibiting RANKL, denosumab reduces bone resorption, thereby increasing bone mass and strength.
Vevzuo is authorised for the prevention of skeletal-related complications in adults with advanced cancers involving bone and for the treatment of giant cell tumour (GCT) of bone in adults and skeletally mature adolescents. Evfraxy, on the other hand, is approved for managing osteoporosis in men and postmenopausal women, as well as for treating bone loss due to hormone ablation therapy in men with prostate cancer at high risk of fractures, and in adults undergoing long-term glucocorticoid therapy.
Clinical trials have demonstrated that both biosimilars are comparable in quality, safety, and efficacy to the reference denosumab product, offering a cost-effective alternative for patients and healthcare providers across Europe.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, stated, “The approval of Vevzuo and Evfraxy in Europe reflects our strong scientific capabilities and our commitment to enhancing access to essential biologics. It also marks our entry into the bone health segment—an important therapeutic area for future growth.”
Over the past 18 months, Biocon Biologics has achieved regulatory approvals for three biosimilars in Europe and two in the UK, demonstrating rapid progress in global expansion. These latest approvals further solidify Biocon’s position as a key player in the biosimilars space, supporting healthcare systems with high-quality, affordable therapeutic options for chronic and complex diseases such as cancer, osteoporosis, and autoimmune conditions.