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EMA accepts MAA for Alvotech’s AVT04 Stelara® (ustekinumab) biosimilar

Feb 9, 2023

Alvotech and STADA announced that EMA has accepted the MAA for Alvotech’s AVT04 biosimilar to Janssen’s Stelara™.  The companies expect the EMA to recommend AVT04 for approval as early as the second half of 2023.  In January 2023, the FDA accepted for review the BLA for AVT04.