Biocon Biologics Secures Market Entry Date for Denosumab Biosimilars in Europe and Rest of the World

Biocon Biologics Ltd., a fully integrated global biosimilars company, has announced a settlement agreement with Amgen Inc. that clears the path for the commercialization of its Denosumab biosimilars in Europe and the rest of the world. The agreement allows Biocon Biologics to commercialize both its Denosumab biosimilars (Vevzuo® and Evfraxy®) in Europe starting December 2, 2025. This settlement follows a previous one in the U.S. and broadens the company's reach across the world in the oncology and bone health therapeutic areas. Denosumab is a human monoclonal antibody that targets and binds a protein known as RANKL, effectively inhibiting the breakdown of bone and leading to increased bone mass and strength. Vevzuo® and Evfraxy® are indicated for the prevention of skeletal related events in adults with advanced malignancies involving bone, treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity, treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.