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 · Company profile
FDAJun 2019approved
EMAFeb 2019authorised
MHRALicenseddate not shown
PMDAJun 2019approved
HCJun 2019approved
CDSCONot listed
EDEDec 2020registered
Approved or registered in 6 of 7 markets
Connections
About Zirabev
Zirabev is Pfizer's bevacizumab, approved in Europe in early 2019 and in the United States and Japan the same summer. It is registered in the UAE and approved in Canada. With Trazimera and Ruxience, it forms Pfizer's set of three cancer antibody biosimilars that are sold together in hospital markets.
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
Reference product in the Purple Book
Avastin
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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 (EMA) · checked Sep 2026
MHRA
United Kingdom · Zirabev
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Zirabev
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
100 mg/4 mL and 400 mg/16 mL vials
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan · Bevacizumab BS [Pfizer]
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Bevacizumab BS [Pfizer]
Holder or applicant
Pfizer Japan
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Jun 2019
Indications as licensed
Unresectable colorectal cancer at approval
Presentations
100 mg and 400 mg vials
Remarks
Bevacizumab Biosimilar 1.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Zirabev
Health CanadaApprovedBrand
Zirabev
Holder or applicant
Pfizer Canada ULC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jun 2019
Application or permission
DIN 02489430, 02489449
Presentations
100, 400 mg
Source
S022 (Health Canada) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Zirabev by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| PF-06439535 | Pfizer | Avastin | Phase 1 | Comparative PK | Completed | Jan 2014 | Aug 2014 | NCT02031991 |
| PF-06439535 | Pfizer | Avastin (as licensed reference) | Phase 1 | Comparative PK | Withdrawn | Jan 2021 | Jul 2021 | NCT04126044 |
Other developers in the same markets
Where Zirabev holds an approval, these are the other bevacizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 5 | Amgen (Mvasi), Bio-Thera Solutions (Avzivi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), mAbxience (Alymsys / Oyavas) |
| EMA | 6 | Amgen (Mvasi), Bio-Thera Solutions (Avzivi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Samsung Bioepis (Aybintio), mAbxience (Alymsys / Oyavas) |
| MHRA | 5 | Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Not stated in the MHRA list (Versavo), Samsung Bioepis (Aybintio), mAbxience (Alymsys / Oyavas) |
| PMDA | 3 | Amgen (Mvasi), Celltrion (Vegzelma), Nichi-Iko Pharmaceutical (Bevacizumab BS Nichi-Iko) |
| HC | 5 | Amgen (Mvasi), Apotex (Bambevi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Samsung Bioepis (Aybintio) |
| EDE | 2 | Amgen (Mvasi), Biocon Biologics (Jobevne / Abevmy / Krabeva) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Pfizer: Abrilada / Amsparity, Ixifi / Zessly, Nivestym / Nivestim, Nyvepria, Ruxience, Trazimera.
Chronology
- EMAFeb 2019Authorised by the European Commission as Zirabev
- HCJun 2019Notice of Compliance, Health Canada as Zirabev
- PMDAJun 2019Approved by MHLW as Bevacizumab BS [Pfizer]
- 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)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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