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 · Company profile
FDAJun 2019approved
EMAMay 2018authorised
MHRANot listed
PMDASep 2018approved
HCFeb 2020approved
CDSCONot listed
EDEFeb 2019registered
Approved or registered in 5 of 7 markets
Connections
About Kanjinti
Kanjinti is Amgen's trastuzumab, approved in Europe in 2018 and in the United States in 2019. It is widely available, with registrations in the UAE and Canada as well, though it is not on the UK product list. In Japan the same product is marketed by Daiichi Sankyo under the Japanese naming convention, though it has since been discontinued there. Amgen sells it through the same oncology channels as its own cancer medicines.
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
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 · 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 (EMA) · checked Sep 2026
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan · Trastuzumab BS Daiichi Sankyo
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Trastuzumab BS Daiichi Sankyo
Holder or applicant
Daiichi Sankyo
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2018
Indications as licensed
HER2-overexpressing breast and gastric cancer
Presentations
60 mg and 150 mg vials
Remarks
Trastuzumab Biosimilar 2; discontinued from marketing.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Kanjinti
Health CanadaApprovedBrand
Kanjinti
Holder or applicant
Amgen Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Feb 2020
Application or permission
DIN 02496690, 02518244
Presentations
150, 420 mg
Source
S022 (Health Canada) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Kanjinti holds an approval, these are the other trastuzumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 5 | Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac) |
| EMA | 7 | Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), EirGenix (Herwenda), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac) |
| PMDA | 2 | Celltrion (Herzuma), Pfizer (Trazimera) |
| HC | 4 | Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), Pfizer (Trazimera), Samsung Bioepis (Ontruzant) |
| EDE | 3 | Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), Pfizer (Trazimera) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Amgen: Amjevita / Amgevita, Avsola, Bkemv / Bekemv, Mvasi, Pavblu, Riabni, Wezlana / Wezenla.
Chronology
- EMAMay 2018Authorised by the European Commission as Kanjinti
- PMDASep 2018Approved by MHLW as Trastuzumab BS Daiichi Sankyo
- EDEFeb 2019Registered in the UAE as Kanjinti
- FDAJun 2019Approved by FDA as Kanjinti
- HCFeb 2020Notice of Compliance, Health Canada 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)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)
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