U.S. License Holder:
Accord BioPharma / Shanghai Henlius Biotech
Date of License:
aBLA accepted by FDA February-2023
HLX02 (trastuzumab) is not FDA-approved. An aBLA has been accepted by the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Zercepac (trastuzumab) (Shanghai Henlius Biotech / Accord Healthcare Ltd.) (July-2020)
Biosimilars Approved In Australia
Tuzucip® / Trastucip® (trastuzumab) (Shanghai Henlius Biotech / Cipla) (July-2022)