Posted by Michael Wonder on 11 Jan 2024
STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara
10 January 2024 - Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity data, including the AVT04-GL-301 confirmatory comparative efficacy and safety clinical trial in patients with moderate to severe chronic plaque-type psoriasis.
Partners STADA and Alvotech today announced that the European Commission issued a marketing authorisation for Uzpruvo (AVT04), a biosimilar candidate to Stelara (ustekinumab).
