FDA.reportPublic FDA data

Abrilada Purple Book BLA 761118

BLA number
761118
Proprietary names
Abrilada
Proper names
adalimumab-afzb
Applicant
Pfizer 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
001Abriladaadalimumab-afzb351(k) Interchangeable40MG/0.8MLInjectionSubcutaneousAutoinjectorRxLicensed2019-11-15
002Abriladaadalimumab-afzb351(k) Interchangeable40MG/0.8MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2019-11-15
003Abriladaadalimumab-afzb351(k) Interchangeable20MG/0.4MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2019-11-15
004Abriladaadalimumab-afzb351(k) Interchangeable10MG/0.2MLInjectionSubcutaneousPre-Filled SyringeDiscLicensed2019-11-15
005Abriladaadalimumab-afzb351(k) Interchangeable40MG/0.8MLInjectionSubcutaneousSingle-Dose VialRxLicensed2019-11-15

Reference Biological Product#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125057Humiraadalimumab351(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
2024-07-01U004Abrilada351(k) InterchangeableDiscPfizer Inc.
2023-10-01U001Abrilada351(k) InterchangeableRxPfizer Inc.
2023-10-01U002Abrilada351(k) InterchangeableRxPfizer Inc.
2023-10-01U003Abrilada351(k) InterchangeableRxPfizer Inc.
2023-10-01U004Abrilada351(k) InterchangeableRxPfizer Inc.
2023-10-01U005Abrilada351(k) InterchangeableRxPfizer Inc.
2023-06-01U001Abrilada351(k) BiosimilarRxPfizer Inc.
2023-06-01U002Abrilada351(k) BiosimilarRxPfizer Inc.
2023-06-01U003Abrilada351(k) BiosimilarRxPfizer Inc.
2023-06-01U004Abrilada351(k) BiosimilarRxPfizer Inc.
2023-06-01U005Abrilada351(k) BiosimilarRxPfizer Inc.
2022-04-01U001Abrilada351(k) BiosimilarDiscPfizer Inc.
2022-04-01U002Abrilada351(k) BiosimilarDiscPfizer Inc.
2022-04-01U003Abrilada351(k) BiosimilarDiscPfizer Inc.
2022-04-01U004Abrilada351(k) BiosimilarDiscPfizer Inc.
2022-04-01U005Abrilada351(k) BiosimilarDiscPfizer Inc.
2021-06-01U001Abrilada351(k) BiosimilarRxPfizer Inc.
2021-06-01U002Abrilada351(k) BiosimilarRxPfizer Inc.
2021-06-01U003Abrilada351(k) BiosimilarRxPfizer Inc.
2021-06-01U004Abrilada351(k) BiosimilarRxPfizer Inc.
2021-06-01U005Abrilada351(k) BiosimilarRxPfizer Inc.
2020-09-01U001Abrilada351(k) BiosimilarRxPfizer, Inc.
2020-09-01U002Abrilada351(k) BiosimilarRxPfizer, Inc.
2020-09-01U003Abrilada351(k) BiosimilarRxPfizer, Inc.
2020-09-01U004Abrilada351(k) BiosimilarRxPfizer, Inc.
2020-09-01U005Abrilada351(k) BiosimilarRxPfizer, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2024-07-01004Abrilada351(k) InterchangeableDiscLicensed2019-11-15
2023-10-01001Abrilada351(k) InterchangeableRxLicensed2019-11-15
2023-10-01002Abrilada351(k) InterchangeableRxLicensed2019-11-15
2023-10-01003Abrilada351(k) InterchangeableRxLicensed2019-11-15
2023-10-01004Abrilada351(k) InterchangeableRxLicensed2019-11-15
2023-10-01005Abrilada351(k) InterchangeableRxLicensed2019-11-15
2023-06-01001Abrilada351(k) BiosimilarRxLicensed2019-11-15
2023-06-01002Abrilada351(k) BiosimilarRxLicensed2019-11-15
2023-06-01003Abrilada351(k) BiosimilarRxLicensed2019-11-15
2023-06-01004Abrilada351(k) BiosimilarRxLicensed2019-11-15
2023-06-01005Abrilada351(k) BiosimilarRxLicensed2019-11-15
2022-04-01001Abrilada351(k) BiosimilarDiscLicensed2019-11-15
2022-04-01002Abrilada351(k) BiosimilarDiscLicensed2019-11-15
2022-04-01003Abrilada351(k) BiosimilarDiscLicensed2019-11-15
2022-04-01004Abrilada351(k) BiosimilarDiscLicensed2019-11-15
2022-04-01005Abrilada351(k) BiosimilarDiscLicensed2019-11-15
2020-05-01001Abrilada351(k) BiosimilarRxLicensed2019-11-15
2020-05-01002Abrilada351(k) BiosimilarRxLicensed2019-11-15
2020-05-01003Abrilada351(k) BiosimilarRxLicensed2019-11-15
2020-05-01004Abrilada351(k) BiosimilarRxLicensed2019-11-15
2020-05-01005Abrilada351(k) BiosimilarRxLicensed2019-11-15
2020-02-01001Abrilada351(k) BiosimilarMarketedLicensed2019-11-15
2020-02-01002Abrilada351(k) BiosimilarMarketedLicensed2019-11-15
2020-02-01003Abrilada351(k) BiosimilarMarketedLicensed2019-11-15
2020-02-01004Abrilada351(k) BiosimilarMarketedLicensed2019-11-15
2020-02-01005Abrilada351(k) BiosimilarMarketedLicensed2019-11-15