European Commission Approves Biocon Biologics’ Denosumab Biosimilars, Vevzuo® and Evfraxy®
Biocon Biologics Ltd (BBL) has 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. 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.
Key Highlights
- Biocon Biologics has secured marketing authorisation for Vevzuo® and Evfraxy® biosimilars of Denosumab in the EU.
- 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.
- 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.
- This approval marks a significant milestone in Biocon Biologics' rapid expansion and support for healthcare systems in the region.