Dr. Reddy’s gets European Commission approval for denosumab biosimilar AVT03

Dr. Reddy’s Laboratories Ltd. on Monday said the European Commission has granted market authorisation for AVT03, its proposed biosimilar to Prolia and Xgeva. The approval covers all EU member states and the European Economic Area, including Iceland, Liechtenstein, and Norway, the company said in an exchange filing.

AVT03 is a human monoclonal antibody used to treat osteoporosis and other bone-related conditions. It is a biosimilar candidate to Prolia and Xgeva, which contain denosumab in different presentations. Denosumab binds to the RANK ligand protein to reduce osteoclast activity, helping to slow bone resorption and cancer-induced bone damage, the company said.