Biocon Biologics gets EU approval for Denosumab biosimilars

Denosumab biosimilars Vevzuo and Evfraxy are used for treating various bone diseases. The approvals mark a key step in the company’s European expansion and reinforce its commitment to affordable biologic therapies

New Delhi: Biocon Ltd on Thursday said its arm Biocon Biologics Ltd has been granted marketing authorisation by the European Commission for Vevzuo and Evfraxy biosimilars of Denosumab used in the treatment of different bone diseases.

The marketing authorisation for the European Union (EU) follows a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025, Biocon Ltd said in a regulatory filing.

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Vevzuo is authorised for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour (GCT) of bone.

Evfraxy is authorised for the treatment of osteoporosis in men and postmenopausal women, the treatment of bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures or the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults, the company 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,” Biocon Biologics CEO & Managing Director Shreehas Tambe said.

Further, Tambe said, “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.”