Biocon Biologics gets marketing authorisation from EC for Denosumab Biosimilars Vevzuo and Evfraxy
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd and a leading global biosimilars company, has received marketing authorisation from the European Commission (EC) for its biosimilars Vevzuo® and Evfraxy®, both referencing Denosumab. This regulatory milestone allows the company to market the two products across the European Union (EU), marking a significant step in its journey to expand its presence in advanced biologics.
Vevzuo® has been approved for the prevention of skeletal-related events in adults suffering from advanced cancers that involve bone, as well as for the treatment of giant cell tumour (GCT) of bone in adults and skeletally mature adolescents. On the other hand, Evfraxy® has been cleared for a broader range of uses in bone health, including the treatment of osteoporosis in men and postmenopausal women. It is also authorised for treating bone loss associated with hormone ablation therapy in men with prostate cancer and long-term systemic glucocorticoid therapy in adults.
Both biosimilars have demonstrated comparable quality, safety, and efficacy to the reference Denosumab product based on comprehensive clinical trial data. This approval from the EC follows a positive recommendation issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025.
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Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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