Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has entered into 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. Under the agreement, Biocon Biologics can commercialize both its Denosumab biosimilars, Vevzuo and Evfraxy, in Europe starting December 2, 2025, while other terms of the settlement remain confidential.
“This settlement sets the stage for Biocon Biologics to bring our Denosumab biosimilars, Vevzuo and Evfraxy, to patients across Europe and key international markets,” said Shreehas Tambe, CEO & Managing Director, Biocon Biologics. “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 approved Vevzuo and Evfraxy in July 2025, and Biocon Biologics has previously secured a market entry date for its Denosumab biosimilars Bosaya (denosumab‑kyqq) and Aukelso (denosumab‑kyqq) in the United States. Denosumab is a human monoclonal antibody targeting RANKL, a key protein involved in the formation, function and survival of osteoclasts, and by blocking RANKL, it inhibits bone resorption and increases bone mass and strength.
Vevzuo, a denosumab biosimilar, is indicated for the prevention of skeletal‑related events such as pathological fractures, radiation to bone, spinal cord compression or surgery to bone in adults with advanced malignancies involving bone, and for the treatment of adults and skeletally mature adolescents with unresectable giant cell tumour of bone or where surgery would likely result in severe morbidity. Evfraxy, also a denosumab biosimilar, is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, for bone loss associated with hormone ablation in men with prostate cancer at increased fracture risk, and for bone loss linked to long‑term systemic glucocorticoid therapy in adults at increased fracture risk.
Biocon Biologics is a global biosimilars company serving over 6 million patients across more than 120 countries, with 10 commercialized biosimilars and a pipeline of 20 assets across diabetology, oncology, immunology, ophthalmology, bone health and other non‑communicable diseases. Leveraging cutting‑edge science, innovative technology platforms, large‑scale manufacturing and world‑class quality systems, the company aims to expand affordable access to high‑quality biological therapeutics while advancing its broader environmental, social and governance commitments.
