European Commission approves Uzpruvo (AVT04), a ustekinumab biosimilar
Partners STADA and Alvotech announced that the European Commission issued a marketing authorization for Uzpruvo (AVT04), a biosimilar candidate to Stelara (ustekinumab)
The centralized marketing authorization for Europe’s first ustekinumab biosimilar is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway. This European marketing authorization for Uzpruvo paves the way for market entry as soon as possible, following the expiry in July 2024 of a European Supplementary Protection Certificate (SPC) for Stelara.
Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing biologic therapy within gastroenterology, dermatology, and rheumatology.
In its most recent annual report, J&J disclosed that the last Stelara “composition of matter” patent — the type of intellectual property that protects the underlying drug and is generally regarded as the most impervious to legal challenge — is due to expire in September 2023.
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