Biocon Biologics has received the European Commission (EC) marketing authorisation for its Denosumab biosimilars, Vevzuo and Evfraxy, in the European Union (EU).
The biosimilars are designed to improve bone health by preventing complications and treating conditions such as osteoporosis and bone loss.
The EC approval follows a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 25 April 2025.
Vevzuo is intended for preventing skeletal-related events in adults with advanced cancer involving bone and treating giant cell tumour of bone in adults and mature adolescents.
Evfraxy treats osteoporosis in men and postmenopausal women, bone loss due to hormone ablation in men with prostate cancer and long-term glucocorticoid therapy in adults.
Biocon Biologics CEO and managing director Shreehas Tambe said: “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.”
Vevzuo is indicated for preventing skeletal-related events such as pathological fractures and spinal cord compression in adults with advanced malignancies involving bone.
It is also used for treating giant cell tumour of bone that is either unresectable or where surgery could lead to severe complications.
Evfraxy is indicated for treating osteoporosis in postmenopausal women and men at increased fracture risk, reducing the risk of vertebral, non-vertebral, and hip fractures.
The drug also addresses bone loss linked to hormone ablation in men with prostate cancer and long-term glucocorticoid therapy in adults.
In the clinical trials, both biosimilars of Denosumab showed comparable quality, safety, and efficacy to the original reference product.
Denosumab is a human monoclonal antibody that targets the RANKL protein, crucial for osteoclast function, inhibiting bone resorption and enhancing bone mass and strength.
Recently, Fresenius Kabi has introduced two new biosimilars of Denosumab, Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) in the US. The denosumab biosimilars are approved by the FDA for all indications of the reference products, Prolia (denosumab) and Xgeva (denosumab), respectively.
