Posted by Michael Wonder on 23 Sep 2025
EMA recommends marketing authorisation of AVT03, Alvotech’s proposed biosimilar to Prolia and Xgeva
22 September 2025 - Alvotech today announced that the EMA's CHMP has adopted a positive opinion recommending approval for AVT03, Alvotech’s proposed biosimilar to Prolia (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva (denosumab 70 mg/mL single use vial).
Pending approval, the biosimilar will be marketed by Alvotech’s commercial partners, STADA Arzneimittel and Dr. Reddy’s Laboratories, each partner with semi-exclusive commercial rights in Europe, including Switzerland and the UK.
