Herzuma

Trastuzumab biosimilar developed by Celltrion, development code CT-P6. Reference product Herceptin.

Brands by market: Herzuma (USA, EU, UAE) · Commercial partner or holder: Celltrion; Hikma (UAE) · Company profile

FDADec 2018approved

EMAFeb 2018authorised

MHRALicenseddate not shown

PMDAMar 2018approved

HCSep 2019approved

CDSCONot listed

EDEApr 2020registered

Approved or registered in 6 of 7 markets

Connections

Trastuzumabmolecule Celltriondeveloper 6 of 7markets 0trials behind it 9other products, same developer 7rival developers in its markets

About Herzuma

Herzuma is Celltrion's trastuzumab, approved in Europe in early 2018 and in the United States at the end of that year. In Japan it was the first trastuzumab biosimilar, approved in 2018 and marketed by Nippon Kayaku. In the UAE it is registered through Hikma, Celltrion's manufacturing partner in Jordan, and it also holds a Canadian approval. Celltrion has since expanded its Japanese and Gulf presence with the same partner model.

Status by market

FDA

United States · Herzuma

US Food and Drug AdministrationApproved

Brand

Herzuma

Holder or applicant

CELLTRION, Inc.

Pathway

351(k)

Approved

Dec 2018

Application or permission

761091

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 · Herzuma

European Medicines Agency and European CommissionApproved

Brand

Herzuma

Holder or applicant

Celltrion Healthcare Hungary Kft.

Pathway

Centralised (Article 10(4))

Approved

Feb 2018

Application or permission

EMEA/H/C/002575

Indications as licensed

Early and metastatic breast cancer, metastatic gastric cancer

Presentations

see SmPC

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Herzuma

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Herzuma

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

150 mg and 420 mg vials

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan · Trastuzumab BS NK

Pharmaceuticals and Medical Devices Agency and MHLWApproved

Brand

Trastuzumab BS NK

Holder or applicant

Celltrion Healthcare Japan (marketed by Nippon Kayaku)

Pathway

Biosimilar (MHLW approval on PMDA review)

Approved

Mar 2018

Indications as licensed

HER2-overexpressing gastric cancer at approval

Presentations

60 mg and 150 mg vials

Remarks

Trastuzumab Biosimilar 1; the CTH-branded version is discontinued.

Source

S020 (PMDA) · checked Sep 2026

Canada · Herzuma

Health CanadaApproved

Brand

Herzuma

Holder or applicant

Celltrion INC.

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Sep 2019

Application or permission

DIN 02480794, 02506211

Presentations

150, 440 mg

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Herzuma

Emirates Drug EstablishmentRegistered

Brand

Herzuma

Holder or applicant

Hikma Pharmaceuticals, Jordan (for Celltrion) · UAE supplier Alphamed Drug Store

Pathway

Registered medical product

Registered

Apr 2020

Presentations

150 mg and 440 mg vials

Source

S018 (UAE Emirates Drug Establishment) · checked Sep 2026

Other developers in the same markets

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

Market	Rivals	Developers (product)
FDA	5	Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac)
EMA	7	Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), EirGenix (Herwenda), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac)
MHRA	5	Biocon Biologics (Ogivri / CANMAb), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac)
PMDA	2	Amgen (Kanjinti), Pfizer (Trazimera)
HC	4	Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Pfizer (Trazimera), Samsung Bioepis (Ontruzant)
EDE	3	Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Pfizer (Trazimera)

Same developer, other molecules

Other biosimilars in the Atlas developed by Celltrion: Avtozma, Eydenzelt, Omlyclo, Remsima / Inflectra, Steqeyma, Stoboclo / Osenvelt, Truxima / Blitzima, Vegzelma, Yuflyma.

Chronology

EMAFeb 2018Authorised by the European Commission as Herzuma
PMDAMar 2018Approved by MHLW as Trastuzumab BS NK
FDADec 2018Approved by FDA as Herzuma
HCSep 2019Notice of Compliance, Health Canada as Herzuma
EDEApr 2020Registered in the UAE as Herzuma

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)
S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All trastuzumab biosimilars

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Data current to September 2026.