Hercessi (trastuzumab-strf)

aBL 761346

Hercessi (trastuzumab-strf)

aBL 761346

U.S. License Holder:

Accord BioPharma / Shanghai Henlius Biotech

Date of License:

April-25-2024

Last Update:

Nov-15-2024

approved_indications 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_indications 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)

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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