Mvasi
Bevacizumab biosimilar developed by Amgen, development code ABP 215. Reference product Avastin.
Brands by market: Mvasi (USA, EU, UAE) · Commercial partner or holder: Amgen
FDASep 2017approved
EMAJan 2018authorised
CDSCOnot listed
EDEApr 2020registered
Status by market
FDA
United States · Mvasi
US Food and Drug AdministrationApprovedBrand
Mvasi
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
Sep 2017
Application or permission
761028
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg/4 mL, 400 mg/16 mL
Note
First FDA-approved oncology biosimilar.
Source
S001, S016
EMA
European Union · Mvasi
European Medicines Agency and European CommissionApprovedBrand
Mvasi
Holder or applicant
Amgen Technology (Ireland) UC
Pathway
Centralised (Article 10(4))
Approved
Jan 2018
Application or permission
EMEA/H/C/004728
Indications as licensed
Colorectal, breast, NSCLC, renal, ovarian, cervical cancer
Presentations
see SmPC
Note
First EU bevacizumab biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Mvasi
Emirates Drug EstablishmentRegisteredBrand
Mvasi
Holder or applicant
Amgen Technology (Ireland) Unlimited Company · UAE supplier Pharmatrade
Pathway
Registered medical product
Registered
Apr 2020
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S018
Chronology
- FDASep 2017Approved by FDA as Mvasi
- EMAJan 2018Authorised by the European Commission as Mvasi
- EDEApr 2020Registered in the UAE as Mvasi
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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