Biocon Biologics gets UK’s MHRA approval for Denosumab biosimilars
The company also secured European Commission authorisation, enabling the launch across the EU and EEA regions
New Delhi: Biocon Ltd on Monday said its arm Biocon Biologics Ltd has received marketing authorisations from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for Vevzuo and Evfraxy, biosimilars of Denosumab used in the treatment of bone-related diseases.
Vevzuo is authorised 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, Biocon said in a regulatory filing.
It is also authorised 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.
On the other hand, Evfraxy is authorised for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, the company said. In postmenopausal women, this significantly reduces the risk of vertebral, non-vertebral, and hip fractures, it added.
Evfraxy is also authorised for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Biocon Biologics was recently granted marketing authorisation for Denosumab biosimilars by the European Commission (EC), allowing their commercialisation in all European Union (EU) member states and the European Economic Area (EEA), the company said.
