Biocon Biologics receives UK approval for denosumab biosimilars

Biocon Biologics Ltd today announced that it has received marketing authorization in the United Kingdom from the Medicines and Healthcare products Regulatory Agency (MHRA) for its Vevzuo® and Evfraxy® biosimilars of Denosumab. Vevzuo® is authorized for the prevention of skeletal-related events in adults with advanced malignancies involving bone, as well as for treating giant cell tumor of bone in adults and skeletally mature adolescents. Evfraxy® is authorized for treating osteoporosis in postmenopausal women and men at increased risk of fractures, as well as bone loss associated with hormone ablation in men with prostate cancer, and bone loss associated with long-term systemic glucocorticoid therapy in adults. The company states that clinical data shows both Denosumab biosimilars have comparable safety and efficacy to the reference product.