U.S. License Holder:
Sandoz / EirGenix
Date of License:
aBLA submitted to FDA December-2021
Last Update:
Sep-30-2024
FDA-Approved Indications
EG12014 (trastuzumab) is not FDA-approved. An aBLA has been submitted to the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Herwenda® (EirGenix / Sandoz) (November-2023)