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 · Company profile
FDASep 2017approved
EMAJan 2018authorised
MHRANot listed
PMDASep 2019approved
HCApr 2018approved
CDSCONot listed
EDEApr 2020registered
Approved or registered in 5 of 7 markets
Connections
About Mvasi
Mvasi is Amgen's bevacizumab, the first cancer biosimilar approved in the United States, in September 2017, and the first bevacizumab biosimilar in Europe, in January 2018. Its US launch waited until 2019 under a settlement with the originator. It is approved in Japan under Amgen's own name, in Canada, and registered in the UAE. Amgen developed it alongside Kanjinti, its trastuzumab, as a pair for oncology tenders.
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
Reference product in the Purple Book
Avastin
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 mg/4 mL, 400 mg/16 mL
Remarks
First FDA-approved oncology biosimilar.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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
Remarks
First EU bevacizumab biosimilar.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan · Bevacizumab BS Amgen
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Bevacizumab BS Amgen
Holder or applicant
Amgen K.K.
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2019
Indications as licensed
Unresectable colorectal cancer at approval
Presentations
100 mg and 400 mg vials
Remarks
Bevacizumab Biosimilar 2.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Mvasi
Health CanadaApprovedBrand
Mvasi
Holder or applicant
Amgen Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Apr 2018
Application or permission
DIN 02470748, 02470756
Presentations
25 mg
Source
S022 (Health Canada) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Mvasi holds an approval, these are the other bevacizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 5 | Bio-Thera Solutions (Avzivi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Pfizer (Zirabev), mAbxience (Alymsys / Oyavas) |
| EMA | 6 | Bio-Thera Solutions (Avzivi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Pfizer (Zirabev), Samsung Bioepis (Aybintio), mAbxience (Alymsys / Oyavas) |
| PMDA | 3 | Celltrion (Vegzelma), Nichi-Iko Pharmaceutical (Bevacizumab BS Nichi-Iko), Pfizer (Zirabev) |
| HC | 5 | Apotex (Bambevi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Pfizer (Zirabev), Samsung Bioepis (Aybintio) |
| EDE | 2 | Biocon Biologics (Jobevne / Abevmy / Krabeva), Pfizer (Zirabev) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Amgen: Amjevita / Amgevita, Avsola, Bkemv / Bekemv, Kanjinti, Pavblu, Riabni, Wezlana / Wezenla.
Chronology
- FDASep 2017Approved by FDA as Mvasi
- EMAJan 2018Authorised by the European Commission as Mvasi
- HCApr 2018Notice of Compliance, Health Canada as Mvasi
- PMDASep 2019Approved by MHLW as Bevacizumab BS Amgen
- 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)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)
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