Biocon Biologics Ltd , a fully integrated global biosimilars company and subsidiary of Biocon Ltd., announced that the European Commission (EC) has granted marketing authorisation in the European Union for Vevzuo and Evfraxy biosimilars of Denosumab. 

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.

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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 treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults.

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

The marketing authorisation follows a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025. 

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., 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”.  

Molecule Information:

Denosumab is a human monoclonal antibody that targets and binds a protein known as RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand). RANKL plays a crucial role in the formation, function, and survival of osteoclasts, which are the cells responsible for bone resorption. By blocking RANKL, denosumab effectively inhibits the breakdown of bone, leading to increased bone mass and strength.

Full indications:

Vevzuo (denosumab biosimilar)

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.

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.

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Evfraxy (denosumab biosimilar)

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral, and hip fractures.

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, denosumab significantly reduces the risk of vertebral fractures.

Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

Epidemiology:

 Osteoporosis is a health condition that weakens bones, making them fragile and more likely to break. It develops slowly over several years and is often only diagnosed when a fall or sudden impact causes a bone to fracture. Across Europe, 32 million individuals aged 50+ were estimated to have osteoporosis in 2019, 25.5 million of which were women. According to the Royal Osteoporosis Society in the UK, one in five men over the age of 50 are likely to break a bone because of osteoporosis.

Nearly all types of cancer can spread to the bone and cause pain and fractures. The number of new cancer cases in the EU reached 2.74 million in 2022.

Giant cell tumour (GCT) is a type of benign (noncancerous) tumour that typically occurs in young adults between the ages of 20 and 40. They can be locally aggressive, meaning that they can grow quickly and destroy surrounding bone and soft tissue. GCTs represent 3–5% of primary bone tumours in the United States and Europe. 

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Source – PR Newswire