Pharm'Up 
Biocon Biologics Ltd. (BBL), a leading global biosimilars company and subsidiary of Biocon Ltd., has received marketing authorizations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its Denosumab biosimilars, Vevzuo® and Evfraxy®.
Vevzuo® is approved for preventing skeletal-related events, such as pathological fractures, radiation to bone, spinal cord compression, or the need for bone surgery in adults with advanced cancers that have metastasized to the bone. It is also authorized for treating adults and skeletally mature adolescents with unresectable giant cell tumors of bone or cases where surgery could lead to severe complications.
Evfraxy® is indicated for osteoporosis treatment in postmenopausal women and men at increased fracture risk, significantly reducing the likelihood of vertebral, non-vertebral, and hip fractures. It is also approved for managing bone loss in men undergoing hormone ablation therapy for prostate cancer, lowering vertebral fracture risk, and for treating bone loss in adults on long-term systemic glucocorticoid therapy at elevated fracture risk.
Clinical data confirm that both biosimilars are comparable in safety and efficacy to the reference product. These UK approvals come on the heels of marketing authorization from the European Commission (EC), enabling commercialization across all EU member states and European Economic Area (EEA) countries.
This milestone reinforces Biocon Biologics’ commitment to delivering high-quality, cost-effective biologics to global markets.
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