The agreement allows Biocon Biologics to commercialize both its Denosumab biosimilars (Vevzuo and Evfraxy) in Europe starting December 2, 2025. The other terms of the settlement remain confidential.
Denosumab is a human monoclonal antibody that targets and binds a protein known as RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand). RANKL plays a crucial role in the formation, function, and survival of osteoclasts, which are the cells responsible for bone resorption. By blocking RANKL, denosumab effectively inhibits the breakdown of bone, leading to increased bone mass and strength.
Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, “This settlement sets the stage for Biocon Biologics to bring our Denosumab biosimilars, Vevzuo and Evfraxy, to patients across Europe and key international markets. This follows our settlement in the U.S. in October and further broadens our reach across the world in the oncology and bone health therapeutic areas, as we work with healthcare systems to expand access to affordable biologics globally.”
The European Commission (EC) had approved Vevzuo and Evfraxy in July 2025.
Vevzuo (denosumab biosimilar) is used for prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. It is also indicated for 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.
Evfraxy (denosumab biosimilar) is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral, and hip fractures.
Biocon Biologics had secured a market entry date for its Denosumab biosimilars Bosaya (denosumab- kyqq) and Aukelso (denosumab-kyqq) for the United States previously.
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