U.S. License Holder:
Alvotech / Teva
Date of License:
aBLA accepted by FDA January-2023; Complete Response Letter October-2023
Last Update:
Mar-08-2024
FDA-Approved Indications
AVT04 (ustekinumab) is not FDA-approved. An aBLA has been accepted by the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Jamteki (Alvotech / JAMP Pharma) (November-2023)
Biosimilars Approved In The E.U.
Uzpruvo® (Alvotech / STADA Arzneimittel) (January-2024)
Biosimilars Approved In Japan
AVT04 (Alvotech / Fuji Pharma) (September-2023)