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
FDAMar 2019approved
EMAJul 2018authorised
CDSCOnot listed
EDEApr 2020registered
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
Presentations
150 mg, 420 mg vials
Source
S001, S016
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
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
Chronology
- EMAJul 2018Authorised by the European Commission as Trazimera
- FDAMar 2019Approved by FDA 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)
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