HLX02 (trastuzumab)

HLX02 Approval Pending

HLX02 (trastuzumab)

HLX02 Approval Pending

U.S. License Holder:

Accord BioPharma / Shanghai Henlius Biotech

Date of License:

aBLA accepted by FDA February-2023

Last Update:

Sep-15-2023

approved_indications FDA-Approved Indications

HLX02 (trastuzumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications 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)

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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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