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STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara

STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara

Accessibility: Skip TopNavReykjavik, ICELANDPartners STADA and Alvotech today announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) has adopted a positive opinion for Uzpruvo (AVT04), a biosimilar candidate to Stelara® (ustekinumab). The positive CHMP opinion for Uzpruvo marks the first time that the EMA has proposed authorizing a biosimilar to the Stelara reference product. A marketing authorization with the indications Crohn’s disease, psoriasis and psoriatic arthritis would be valid across all European Union (EU) member...

November 10, 2023
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