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)
FDADec 2018approved
EMAFeb 2018authorised
CDSCOnot listed
EDEApr 2020registered
Status by market
FDA
United States · Herzuma
US Food and Drug AdministrationApprovedBrand
Herzuma
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Dec 2018
Application or permission
761091
Licence type
351(k) biosimilar, not interchangeable
Presentations
150 mg, 420 mg vials
Source
S001, S016
EMA
European Union · Herzuma
European Medicines Agency and European CommissionApprovedBrand
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Herzuma
Emirates Drug EstablishmentRegisteredBrand
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
Chronology
- EMAFeb 2018Authorised by the European Commission as Herzuma
- FDADec 2018Approved by FDA 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)
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