Biocon Biologics Ltd (BBL), a global biosimilars manufacturer and subsidiary of Biocon Ltd., has reached a settlement agreement with Amgen Inc that enables the commercialization of its Denosumabbiosimilars in Europe and multiple international markets. Under the terms of the agreement, Biocon Biologics will begin marketing both Vevzuo® and Evfraxy® across Europe from December 2, 2025. Other conditions of the settlement remain confidential.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, stated that the development marks an important milestone for the company. He noted that the agreement creates a pathway for patients in Europe and key global regions to access the company’s Denosumabbiosimilars. He added that the settlement follows the company’s earlier resolution in the United States in October and reinforces Biocon Biologics’ commitment to expanding access in therapeutic areas such as oncology and bone health through collaboration with healthcare systems worldwide.
The European Commission approved Vevzuo and Evfraxy in July 2025. Biocon Biologics had already secured a commercial entry date for its DenosumabbiosimilarsBosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq) for the United States.
Denosumab is a human monoclonal antibody that targets and binds RANKL, a protein essential for osteoclast formation and survival. By inhibiting RANKL, Denosumab helps prevent bone resorption, resulting in increased bone mass and strength.
Vevzuo® is approved for the prevention of skeletal-related events such as pathological fractures, spinal cord compression, radiation to bone, 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 cases where surgery would lead to severe morbidity. Evfraxy® is approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, for reducing bone loss associated with hormone ablation in men with prostate cancer at high fracture risk, and for treating bone loss due to long-term systemic glucocorticoid therapy in adults who have an elevated risk of fractures.
Osteoporosis is a progressive condition that weakens bones and is often diagnosed only after a fracture. Across Europe, approximately 32 million people aged 50 and above were estimated to have osteoporosis in 2019, of which 25.5 million were women.
In the United Kingdom, the Royal Osteoporosis Society estimates that one in five men over 50 are likely to sustain a fracture related to the condition. Cancer-related bone metastases affect patients across disease types, with the European Union recording 2.74 million new cancer cases in 2022. Giant cell tumour of bone is a benign yet locally aggressive tumour that typically affects young adults between 20 and 40 years of age and accounts for 3–5% of primary bone tumours in the United States and Europe.
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars enterprise focused on improving access to advanced biological therapies. The company currently provides treatment solutions to more than six million patients across over 120 countries, combining scientific innovation, technological platforms, scaled manufacturing, and internationally benchmarked quality systems to deliver affordable biologics.
Biocon Biologics has commercialized ten biosimilars in major markets including the United States, Europe, Australia, Canada, Japan, and leading emerging regions, supported by a pipeline of twenty biosimilar programs across diabetology, oncology, immunology, ophthalmology, bone health, and other chronic disease segments. The company’s commitment to environmental, social, and governance excellence has earned it a position in the S&P Global Sustainability Yearbook 2025.
