U.S. License Holder:
Accord BioPharma / Shanghai Henlius Biotech
Date of License:
April-25-2024
Last Update:
Dec-15-2024
FDA-Approved Indications
HERCESSI (trastuzumab-strf) is a HER2/neu receptor antagonist indicated for:
The treatment of HER2-overexpressing breast cancer;
The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Adheroza (Intas / Shanghai Henlius Biotech) (August-2024)
Biosimilars Approved In The E.U.
Zercepac (Shanghai Henlius Biotech / Accord Healthcare Ltd.) (July-2020)
Biosimilars Approved In Australia
Tuzucip® / Trastucip® (trastuzumab) (Shanghai Henlius Biotech / Cipla) (July-2022)