Kanjinti
Trastuzumab biosimilar developed by Amgen, development code ABP 980. Reference product Herceptin.
Brands by market: Kanjinti (USA, EU, UAE) · Commercial partner or holder: Amgen
FDAJun 2019approved
EMAMay 2018authorised
CDSCOnot listed
EDEFeb 2019registered
Status by market
FDA
United States · Kanjinti
US Food and Drug AdministrationApprovedBrand
Kanjinti
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Jun 2019
Application or permission
761073
Licence type
351(k) biosimilar, not interchangeable
Presentations
150 mg, 420 mg vials
Source
S001, S016
EMA
European Union · Kanjinti
European Medicines Agency and European CommissionApprovedBrand
Kanjinti
Holder or applicant
Amgen Europe B.V.
Pathway
Centralised (Article 10(4))
Approved
May 2018
Application or permission
EMEA/H/C/004361
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 · Kanjinti
Emirates Drug EstablishmentRegisteredBrand
Kanjinti
Holder or applicant
Amgen Europe B.V. · UAE supplier Pharmatrade
Pathway
Registered medical product
Registered
Feb 2019
Presentations
150 mg and 420 mg vials
Source
S018
Chronology
- EMAMay 2018Authorised by the European Commission as Kanjinti
- EDEFeb 2019Registered in the UAE as Kanjinti
- FDAJun 2019Approved by FDA as Kanjinti
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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