Dr. Reddy's Receives Positive CHMP Opinion from European Medicines Agency for AVT03, a Proposed Biosimilar of Prolia® and Xgeva®

Dr. Reddy’s Laboratories Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation for AVT03, a biosimilar of Prolia® (denosumab) and Xgeva® (denosumab) in European markets. The CHMP positive opinion will now be reviewed by the European Commission (EC) for grant of marketing authorisation in the European Economic Area (EEA). AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia® and Xgeva®, which are both denosumab but in different presentations. 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® (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Xbonzy® (denosumab) 70 mg/mL solution for injection in a vial.