Zirabev
Bevacizumab biosimilar developed by Pfizer, development code PF-06439535. Reference product Avastin.
Brands by market: Zirabev (USA, EU, UAE) · Commercial partner or holder: Pfizer
FDAJun 2019approved
EMAFeb 2019authorised
CDSCOnot listed
EDEDec 2020registered
Status by market
FDA
United States · Zirabev
US Food and Drug AdministrationApprovedBrand
Zirabev
Holder or applicant
Pfizer Inc.
Pathway
351(k)
Approved
Jun 2019
Application or permission
761099
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S001, S016
EMA
European Union · Zirabev
European Medicines Agency and European CommissionApprovedBrand
Zirabev
Holder or applicant
Pfizer Europe MA EEIG
Pathway
Centralised (Article 10(4))
Approved
Feb 2019
Application or permission
EMEA/H/C/004697
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Zirabev
Emirates Drug EstablishmentRegisteredBrand
Zirabev
Holder or applicant
Pfizer Service Company BVBA, Belgium · UAE supplier Gulf Drug LLC
Pathway
Registered medical product
Registered
Dec 2020
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S018
Chronology
- EMAFeb 2019Authorised by the European Commission as Zirabev
- FDAJun 2019Approved by FDA as Zirabev
- EDEDec 2020Registered in the UAE as Zirabev
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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