Business Update24 Nov 2025, 03:42 pm
Dr. Reddy's Receives European Commission Approval for AVT03, a Proposed Biosimilar of Prolia® and Xgeva®
AI Summary
Dr. Reddy’s Laboratories Ltd. announced that the European Commission (EC) has granted marketing authorization for AVT03, a biosimilar of Prolia® (denosumab) and Xgeva® (denosumab). The EC decision is valid in all EU Member States as well as in the European Economic Area (EEA) countries. Dr. Reddy’s and Alvotech entered into a license and supply agreement for the commercialization of AVT03 in May 2024. Upon approval, Dr. Reddy’s will offer the biosimilar under the tradenames Acvybra® and Xbonzy®. AVTO3 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia® and Xgeva®.
Key Highlights
- Dr. Reddy’s receives European Commission approval for AVT03, a proposed biosimilar of Prolia® and Xgeva®
- AVT03 is a biosimilar of Prolia® (denosumab) and Xgeva® (denosumab)
- EC decision is valid in all EU Member States as well as in the European Economic Area (EEA) countries
- Dr. Reddy’s and Alvotech entered into a license and supply agreement in May 2024
- Dr. Reddy’s will offer the biosimilar under the tradenames Acvybra® and Xbonzy® upon approval