EMA accepts Alvotech application for denosumab biosimilar

The European Medicines Agency (EMA) has validated the marketing authorization application for AVT03, a proposed biosimilar to the denosumab-based drugs Prolia and Xgeva. This step initiates the formal regulatory review process for the investigational treatment.

The application is supported by data from clinical studies, including results announced in July 2024. These trials, involving both patients with osteoporosis and healthy participants, demonstrated clinical similarity in terms of efficacy, safety, immunogenicity, and pharmacokinetics when compared to the reference products. Alvotech, based in Iceland, operates an integrated platform for the development and manufacture of biosimilars.

Market data suggests the European denosumab market is valued at approximately $1 billion. To handle future commercialization, Alvotech has established agreements with STADA Arzneimittel AG and Dr. Reddy’s Laboratories, which hold semi-exclusive rights for distribution across Europe, including Switzerland and the UK.

Prolia is widely used for osteoporosis management, while Xgeva is indicated for patients with advanced cancer affecting the bone. As a biosimilar, AVT03 aims to expand patient access through competitive pricing. The candidate remains experimental and has not yet received regulatory approval in any jurisdiction.