European Commission Approves Uzpruvo, First Ustekinumab Biosimilar in Europe

The European Commission has granted marketing authorization for Uzpruvo® (AVT04), the first ustekinumab biosimilar to Stelara®, valid in all European Economic Area (EEA) countries. The drug is indicated for treatments in gastroenterology, dermatology, and rheumatology.

The approval, secured by STADA and Alvotech, opens the door for biosimilar competition in the EU ustekinumab market, valued at approximately €2.5 billion. Market entry is expected soon after the expiry of Stelara®'s intellectual property rights in July 2024.

Uzpruvo's authorization is based on a comprehensive package of analytical, non-clinical, and clinical similarity data. This included a comparative efficacy and safety clinical trial in patients with moderate to severe chronic plaque psoriasis.

The partnership between Alvotech and STADA, established in 2019, focuses on the development and manufacturing of biosimilars. STADA holds the commercial rights in Europe, where the company already markets six biosimilar products.