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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) · Company profile
FDAApr 2024approved
EMAJul 2020authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
TrastuzumabmoleculeShanghai Henlius Biotechdeveloper3 of 7markets1trial behind it2other products, same developer7rival developers in its markets

About Hercessi / Zercepac

Hercessi is Henlius's trastuzumab, sold in the United States by Accord since its approval in 2024, and in Europe under the name Zercepac since 2020. Henlius, based in Shanghai, was among the first Chinese companies to bring an antibody biosimilar to Western markets, and Accord, the European and American arm of India's Intas, is its commercial partner for both.

Status by market

FDA

United States · Hercessi

US Food and Drug AdministrationApproved
Brand
Hercessi
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
Apr 2024
Application or permission
761346
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Herceptin
Marketing status (Purple Book)
Prescription, marketed
Presentations
150 mg, 420 mg vials
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Zercepac

European Medicines Agency and European CommissionApproved
Brand
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 (EMA) · checked Sep 2026
MHRA

United Kingdom · Zercepac

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Zercepac
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
60 mg, 150 mg and 420 mg vials
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Hercessi / Zercepac by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
HLX02Shanghai Henlius BiotechHerceptinPhase 3Comparative efficacyCompletedNov 2016Nov 2018NCT03084237

Other developers in the same markets

Where Hercessi / Zercepac holds an approval, these are the other trastuzumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA5Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), Pfizer (Trazimera), Samsung Bioepis (Ontruzant)
EMA7Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), EirGenix (Herwenda), Pfizer (Trazimera), Samsung Bioepis (Ontruzant)
MHRA5Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), Pfizer (Trazimera), Samsung Bioepis (Ontruzant)

Same developer, other molecules

Other biosimilars in the Atlas developed by Shanghai Henlius Biotech: Bildyos / Bilprevda, Poherdy.

Chronology

Sources

All trastuzumab biosimilars

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Data current to September 2026.