Biocon Biologics secures European market entry for denosumab biosimilars

Biocon Biologics Ltd. announced on December 2, 2025, that it has reached a settlement agreement with Amgen Inc., which grants Biocon Biologics the right to commercialize its denosumab biosimilars, Vevzuo and Evfraxy, in Europe starting December 2, 2025. This agreement follows an earlier settlement in the U.S. in October, broadening Biocon Biologics' global reach in oncology and bone health.

The European Commission had previously approved Vevzuo and Evfraxy in July 2025. This market entry date also builds on Biocon Biologics' earlier success in securing a market entry date for its denosumab biosimilars, Bosaya and Aukelso, for the United States.

Denosumab is a human monoclonal antibody targeting RANKL, a protein crucial for bone resorption. By blocking RANKL, denosumab inhibits bone breakdown, increasing bone mass and strength. Vevzuo is indicated for preventing skeletal-related events in advanced malignancies and treating giant cell tumors of bone, while Evfraxy is indicated for treating osteoporosis in postmenopausal women and men at increased risk of fractures.