Dr. Reddy’s gets EU Panel Nod for Denosumab Biosimilar

Dr. Reddy’s Laboratories Ltd. on Monday said the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for denosumab-AVT03, a biosimilar to Prolia and Xgeva, in European markets.

Prolia is used to treat osteoporosis in post-menopausal women and men with high fracture risk, as well as bone loss linked to prostate cancer. Xgeva is prescribed to treat bone complications in adults with advanced cancer. Both medicines are owned by Amgen Inc. Dr. Reddy’s is developing the biosimilar with Alvotech.

The European Commission will now review the recommendation before deciding on marketing authorisation in the European Economic Area, which covers the European Union, Norway, Iceland, and Liechtenstein. Dr. Reddy’s said it will also file a separate application with the UK’s Medicines and Healthcare products Regulatory Agency.

Under the agreement, Alvotech will develop and manufacture AVT03, while Dr. Reddy’s will handle registration and commercialisation in key markets, including the US and Europe. Dr. Reddy’s has exclusive rights for the US, and semi-exclusive rights for Europe and the UK. If approved, the biosimilar will be launched as Acvybra solution for injection in a pre-filled syringe and Xbonzy solution for injection in a vial.