U.S. License Holder:
Samsung Bioepis / Sandoz
Date of License:
aBLA submitted to FDA on undisclosed date
Last Update:
Apr-23-2024
FDA-Approved Indications
SB17 (ustekinumab) is not FDA-approved. An aBLA has been submitted to the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Pyzchiva® (Sandoz / Samsung Bioepis) (April-2024)
Biosimilars Approved In South Korea
Epyztek (Samsung Bioepis) (April-2024)