Dr. Reddy's biosimilar for Prolia, Xgeva gets positive EU opinion

Dr. Reddy's Laboratories announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for AVT03. This biosimilar candidate targets both Prolia® (denosumab) and Xgeva® (denosumab), marking a significant step towards commercialization in European markets.

The positive CHMP opinion will now be reviewed by the European Commission (EC) for a final decision on marketing authorisation across the European Economic Area (EEA), including EU member countries, Norway, Iceland, and Liechtenstein. A separate Marketing Authorisation Application will be submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA) via the International Recognition Procedure.

This development follows a May 2024 license and supply agreement between Dr. Reddy's and Alvotech. Alvotech develops and manufactures AVT03, while Dr. Reddy's handles registration and commercialization. Upon approval, Dr. Reddy's will market the biosimilar under the tradenames Acvybra® (denosumab) 60 mg/mL solution for injection and Xbonzy® (denosumab) 70 mg/mL solution for injection, with exclusive commercialization rights for the U.S. and semi-exclusive rights for Europe and the UK.