Biocon Biologics’ Denosumab biosimilars, Vevzuo and Evfraxy, have received marketing authorisation in the European Union (EU).
This approval from the European Commission (EC) allows for their use in bone-related conditions across adult populations.
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Vevzuo received authorisation to prevent bone complications in individuals with advanced cancer in bone and treat giant cell tumour (GCT) of bone in patients who are either adults or skeletally mature adolescents.
The EC also authorised Evfraxy to treat osteoporosis in men at high risk of fractures and postmenopausal women. The drug addresses bone loss due to hormone ablation therapy in men with prostate cancer and is used in long-term systemic glucocorticoid therapy in adults.
Clinical trials have demonstrated that both biosimilars match the reference product’s safety, quality and efficacy standards.
The decision by the EC follows the Committee for Medicinal Products for Human Use’s (CHMP) positive recommendation issued in April 2025.
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By GlobalDataBiocon Biologics CEO and managing director Shreehas Tambe stated: “The approval of Vevzuo and Evfraxy in Europe underscores our strong scientific expertise and commitment to expanding patient access to essential medicines, including to new therapeutic areas such as bone health.
“In the past 18 months, we have successfully secured regulatory approvals for three biosimilars in Europe and two in the UK. These Denosumab biosimilars mark another significant milestone in our rapid expansion, and support for healthcare systems in the region.”
Denosumab, a human-derived monoclonal antibody, specifically attaches to the protein Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL ), which is essential in the development, activity and longevity of osteoclasts, the cells involved with bone resorption.
By inhibiting RANKL, denosumab hampers the bone degradation process, bolstering bone density and strength.
In 2024, the US Food and Drug Administration (FDA) approved 19 biosimilars – a significant increase from the five approved in 2023.
