Biocon Biologics (BBL), a fully integrated global biosimilars company and subsidiary of Biocon, has reached a settlement agreement with Amgen, paving the way for the commercialisation of its Denosumab biosimilars in Europe and other international markets.

Under the agreement, Biocon Biologics will introduce both its Denosumab biosimilars — Vevzuo and Evfraxy — in Europe beginning December 2, 2025. Other terms of the settlement remain confidential.

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 US 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.  Earlier, Biocon Biologics had secured a market entry date for its Denosumab biosimilars Bosaya (denosumabkyqq) and Aukelso (denosumab-kyqq) in the United States.

Denosumab is a human monoclonal antibody that targets and binds a protein known as RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), which plays a crucial role in the formation, function, and survival of osteoclasts – the cells responsible for bone resorption. By blocking RANKL, denosumab effectively inhibits the breakdown of bone, leading to increased bone mass and strength.  

Vevzuo is approved for preventing skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and for treating 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 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. It is also used to manage bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Additionally, Evfraxy is approved for treating bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.