Biocon's biologics arm gets regulatory approval in EU for Denosumab biosimilars

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.

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 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, 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.'

Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions like diabetes, cancer, and autoimmune diseases.

The company's consolidated net profit surged 154.2% to Rs 344.50 crore on a 12.8% jump in net sales to Rs 4,358.10 crore in Q4 FY25 over Q4 FY24.

The scrip shed 0.20% to currently trade at Rs 367.65 on the BSE.

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