FDA accepts BLA for Alvotech’s AVT04 Stelara® (biosimilar) ustekinumab

Jan 6, 2023

Alvotech and Teva announced that the FDA has accepted for review a BLA for AVT04 (biosimilar ustekinumab). Alvotech reported that it expects the review to be completed in the second half of 2023.  AVT04 is being developed under a strategic agreement between Alvotech and Teva announced in August 2020.

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