Biocon Biologics gets marketing nods in UK for Vevzuo, Evfraxy

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-07-07 05:42 GMT   |   Update On 2025-07-07 05:42 GMT
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Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has received marketing authorisations from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for Vevzuo and Evfraxy, biosimilars of Denosumab.

Vevzuo is authorized for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.

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Vevzuo is also authorized for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Evfraxy is authorized for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women this significantly reduces the risk of vertebral, non-vertebral, and hip fractures.

Furthermore, Evfraxy is authorized for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, this significantly reduces the risk of vertebral fractures.

Evfraxy is also authorized for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

Clinical data showed that both Denosumab biosimilars have comparable safety and efficacy to the reference product.

In Europe, the European Commission (EC) recently granted marketing authorisation for Biocon Biologics Denosumab biosimilars, allowing their commercialization in all European Union (EU) member states and the European Economic Area (EEA).

Read also: Biocon Biologics gets EU nod for bone disease treatments, including Osteoporosis, giant cell tumour of bone

Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.

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