Biocon Biologics signed a settlement agreement with Amgen Inc., clearing the path for the commercialisation of Denosumab biosimilars in Europe and other international markets. The agreement enables Biocon Biologics to launch its biosimilars Vevzuo and Evfraxy in Europe starting December 2, 2025. The other terms of the settlement remain confidential.
Expanding Access to Key Therapeutic Areas
“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 of Biocon Biologics. He added, “This follows our settlement in the US in October and further broadens our reach worldwide in the oncology and bone health therapeutic areas, as we work with healthcare systems to expand access to affordable biologics globally.”
Regulatory Approvals and Indications
The European Commission approved both Vevzuo and Evfraxy in July 2025. Vevzuo prevents skeletal-related events in adults with advanced malignancies involving bone. Evfraxy treats osteoporosis in postmenopausal women and in men at increased risk of fractures, among other conditions.
Strengthening Global Biosimilar Presence
As reported by thehindubusinessline.com, the settlement with Amgen complements Biocon Biologics’ earlier US agreement. It strengthens the company’s ability to expand Denosumab biosimilar access globally. It also reinforces Biocon’s commitment to delivering affordable biologics in critical therapeutic areas.
