Trazimera
Trastuzumab biosimilar developed by Pfizer, development code PF-05280014. Reference product Herceptin.
Brands by market: Trazimera (USA, EU, UAE) · Commercial partner or holder: Pfizer · Company profile
FDAMar 2019approved
EMAJul 2018authorised
MHRALicenseddate not shown
PMDASep 2018approved
HCAug 2019approved
CDSCONot listed
EDEApr 2020registered
Approved or registered in 6 of 7 markets
Connections
About Trazimera
Trazimera is Pfizer's trastuzumab, approved in Europe in 2018 and in the United States in 2019, and among the few trastuzumab biosimilars approved in Japan, where Pfizer sells it under its own name. It is registered in the UAE and Canada. Pfizer's oncology biosimilars, including Zirabev and Ruxience, share the same distribution, which gives Trazimera a broad reach in hospital markets.
Status by market
FDA
United States · Trazimera
US Food and Drug AdministrationApprovedBrand
Trazimera
Holder or applicant
Pfizer Ireland Pharmaceuticals Unlimited Company
Pathway
351(k)
Approved
Mar 2019
Application or permission
761081
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 · Trazimera
European Medicines Agency and European CommissionApprovedBrand
Trazimera
Holder or applicant
Pfizer Europe MA EEIG
Pathway
Centralised (Article 10(4))
Approved
Jul 2018
Application or permission
EMEA/H/C/004463
Indications as licensed
Early and metastatic breast cancer, metastatic gastric cancer
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Trazimera
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Trazimera
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 [Pfizer]
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Trastuzumab BS [Pfizer]
Holder or applicant
Pfizer Japan
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 3.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Trazimera
Health CanadaApprovedBrand
Trazimera
Holder or applicant
Pfizer Canada ULC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Aug 2019
Application or permission
DIN 02483467, 02483475
Presentations
150, 440 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Trazimera
Emirates Drug EstablishmentRegisteredBrand
Trazimera
Holder or applicant
Pfizer Manufacturing Belgium NV · UAE supplier Gulf Drug LLC
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 Trazimera 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), Celltrion (Herzuma), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac) |
| EMA | 7 | Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), EirGenix (Herwenda), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac) |
| MHRA | 5 | Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac) |
| PMDA | 2 | Amgen (Kanjinti), Celltrion (Herzuma) |
| HC | 4 | Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), Samsung Bioepis (Ontruzant) |
| EDE | 3 | Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Pfizer: Abrilada / Amsparity, Ixifi / Zessly, Nivestym / Nivestim, Nyvepria, Ruxience, Zirabev.
Chronology
- EMAJul 2018Authorised by the European Commission as Trazimera
- PMDASep 2018Approved by MHLW as Trastuzumab BS [Pfizer]
- FDAMar 2019Approved by FDA as Trazimera
- HCAug 2019Notice of Compliance, Health Canada as Trazimera
- EDEApr 2020Registered in the UAE as Trazimera
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)
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