Biocon Biologics Gets EU Approval For Denosumab Biosimilars Vevzuo And Evfraxy

Biocon Biologics Ltd., a subsidiary of Biocon Ltd., said Thursday it has received marketing authorisation from the European Commission for its Denosumab biosimilars, Vevzuo and Evfraxy, in the European Union.

The approval follows a positive opinion issued on April 25 by the European Medicines Agency’s Committee for Medicinal Products for Human Use, the company said in a press release.

Vevzuo and Evfraxy are indicated for the prevention of bone complications in patients with advanced cancer and giant cell tumour of bone. Both drugs are being marketed by Biosimilar Collaborations Ireland Ltd.

In the past 18 months, Biocon Biologics has secured regulatory clearances for three biosimilars in the EU and two in the UK.