FDA.reportPublic FDA data

Mvasi Purple Book BLA 761028

BLA number
761028
Proprietary names
Mvasi
Proper names
bevacizumab-awwb
Applicant
Amgen Inc.
Center
CDER
First observed release
2020-02-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Mvasibevacizumab-awwb351(k) Biosimilar100MG/4ML (25MG/ML)InjectionIntravenousSingle-Dose VialRxLicensed2017-09-14
002Mvasibevacizumab-awwb351(k) Biosimilar400MG/16ML (25MG/ML)InjectionIntravenousSingle-Dose VialRxLicensed2017-09-14

Reference Biological Product#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125085Avastinbevacizumab351(a)Rx2026-06-01

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2020-10-01U001Mvasi351(k) BiosimilarRxAmgen, Inc.
2020-10-01U002Mvasi351(k) BiosimilarRxAmgen, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Mvasi351(k) BiosimilarRxLicensed2017-09-14
2020-05-01002Mvasi351(k) BiosimilarRxLicensed2017-09-14
2020-02-01001Mvasi351(k) BiosimilarMarketedLicensed2017-09-14
2020-02-01002Mvasi351(k) BiosimilarMarketedLicensed2017-09-14