Hercessi / Zercepac
Trastuzumab biosimilar developed by Shanghai Henlius Biotech, development code HLX02. Reference product Herceptin.
Brands by market: Hercessi (USA); Zercepac (EU) · Commercial partner or holder: Accord BioPharma (USA, EU)
FDAApr 2024approved
EMAJul 2020authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Hercessi
US Food and Drug AdministrationApprovedBrand
Hercessi
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
Apr 2024
Application or permission
761346
Licence type
351(k) biosimilar, not interchangeable
Presentations
150 mg, 420 mg vials
Source
S001, S016
EMA
European Union · Zercepac
European Medicines Agency and European CommissionApprovedBrand
Zercepac
Holder or applicant
Accord Healthcare S.L.U.
Pathway
Centralised (Article 10(4))
Approved
Jul 2020
Application or permission
EMEA/H/C/005209
Indications as licensed
Early and metastatic breast cancer, metastatic gastric cancer
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJul 2020Authorised by the European Commission as Zercepac
- FDAApr 2024Approved by FDA as Hercessi
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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