STADA and Alvotech secure approval for Uzpruvo, Europe’s

From GlobeNewswire:

The European Commission has issued a marketing authorization for Uzpruvo®, a biosimilar to Stelara®, a biologic therapy used in gastroenterology, dermatology, and rheumatology. This authorization paves the way for biosimilar competition in the €2.5 billion EU ustekinumab market, with market entry expected after the expiry of intellectual-property rights in July 2024. The approval for Uzpruvo is based on a comprehensive package of analytical, non-clinical, and clinical data, including the AVT04-GL-301 confirmatory trial in patients with chronic plaque-type psoriasis. STADA and Alvotech announced this exciting development today.



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