FDA.reportPublic FDA data

Amjevita Purple Book BLA 761024

BLA number
761024
Proprietary names
Amjevita
Proper names
adalimumab-atto
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
001Amjevitaadalimumab-atto351(k) Interchangeable20MG/0.4MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2016-09-23
002Amjevitaadalimumab-atto351(k) Interchangeable40MG/0.8MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2016-09-23
003Amjevitaadalimumab-atto351(k) Interchangeable40MG/0.8MLInjectionSubcutaneousAutoinjectorRxLicensed2016-09-23
004Amjevitaadalimumab-atto351(k) Interchangeable10MG/0.2MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2023-04-06
005Amjevitaadalimumab-atto351(k) Interchangeable20MG/0.2MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2023-08-14
006Amjevitaadalimumab-atto351(k) Interchangeable40MG/0.4MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2023-08-14
007Amjevitaadalimumab-atto351(k) Interchangeable80MG/0.8MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2023-08-14
008Amjevitaadalimumab-atto351(k) Interchangeable40MG/0.4MLInjectionSubcutaneousAutoinjectorRxLicensed2023-08-14
009Amjevitaadalimumab-atto351(k) Interchangeable80MG/0.8MLInjectionSubcutaneousAutoinjectorRxLicensed2023-08-14

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
2025-05-01U006Amjevita351(k) InterchangeableRxAmgen Inc.
2025-05-01U008Amjevita351(k) InterchangeableRxAmgen Inc.
2025-04-01U005Amjevita351(k) InterchangeableRxAmgen Inc.
2025-04-01U007Amjevita351(k) InterchangeableRxAmgen Inc.
2025-04-01U009Amjevita351(k) InterchangeableRxAmgen Inc.
2024-08-01U001Amjevita351(k) InterchangeableRxAmgen Inc.
2024-08-01U002Amjevita351(k) InterchangeableRxAmgen Inc.
2024-08-01U003Amjevita351(k) InterchangeableRxAmgen Inc.
2024-08-01U004Amjevita351(k) InterchangeableRxAmgen Inc.
2023-09-01N005Amjevita351(k) BiosimilarRxAmgen Inc.
2023-09-01N006Amjevita351(k) BiosimilarRxAmgen Inc.
2023-09-01N007Amjevita351(k) BiosimilarRxAmgen Inc.
2023-09-01N008Amjevita351(k) BiosimilarRxAmgen Inc.
2023-09-01N009Amjevita351(k) BiosimilarRxAmgen Inc.
2023-08-01N005Amjevita351(k) BiosimilarRxAmgen Inc.
2023-08-01N006Amjevita351(k) BiosimilarRxAmgen Inc.
2023-08-01N007Amjevita351(k) BiosimilarRxAmgen Inc.
2023-08-01N008Amjevita351(k) BiosimilarRxAmgen Inc.
2023-08-01N009Amjevita351(k) BiosimilarRxAmgen Inc.
2023-04-01N004Amjevita351(k) BiosimilarRxAmgen Inc.
2022-03-01U001Amjevita351(k) BiosimilarRxAmgen, Inc.
2022-03-01U002Amjevita351(k) BiosimilarRxAmgen, Inc.
2022-03-01U003Amjevita351(k) BiosimilarRxAmgen, Inc.
2020-10-01U001Amjevita351(k) BiosimilarDiscAmgen, Inc.
2020-10-01U002Amjevita351(k) BiosimilarDiscAmgen, Inc.
2020-10-01U003Amjevita351(k) BiosimilarDiscAmgen, Inc.
2020-06-01U001Amjevita351(k) BiosimilarDiscAmgen Inc.
2020-06-01U002Amjevita351(k) BiosimilarDiscAmgen Inc.
2020-06-01U003Amjevita351(k) BiosimilarDiscAmgen Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2025-05-01006Amjevita351(k) InterchangeableRxLicensed2023-08-14
2025-05-01008Amjevita351(k) InterchangeableRxLicensed2023-08-14
2025-04-01005Amjevita351(k) InterchangeableRxLicensed2023-08-14
2025-04-01007Amjevita351(k) InterchangeableRxLicensed2023-08-14
2025-04-01009Amjevita351(k) InterchangeableRxLicensed2023-08-14
2024-08-01001Amjevita351(k) InterchangeableRxLicensed2016-09-23
2024-08-01002Amjevita351(k) InterchangeableRxLicensed2016-09-23
2024-08-01003Amjevita351(k) InterchangeableRxLicensed2016-09-23
2024-08-01004Amjevita351(k) InterchangeableRxLicensed2023-04-06
2023-08-01005Amjevita351(k) BiosimilarRxLicensed2023-08-14
2023-08-01006Amjevita351(k) BiosimilarRxLicensed2023-08-14
2023-08-01007Amjevita351(k) BiosimilarRxLicensed2023-08-14
2023-08-01008Amjevita351(k) BiosimilarRxLicensed2023-08-14
2023-08-01009Amjevita351(k) BiosimilarRxLicensed2023-08-14
2023-04-01004Amjevita351(k) BiosimilarRxLicensed2023-04-06
2022-03-01001Amjevita351(k) BiosimilarRxLicensed2016-09-23
2022-03-01002Amjevita351(k) BiosimilarRxLicensed2016-09-23
2022-03-01003Amjevita351(k) BiosimilarRxLicensed2016-09-23
2020-06-01001Amjevita351(k) BiosimilarDiscLicensed2016-09-23
2020-06-01002Amjevita351(k) BiosimilarDiscLicensed2016-09-23
2020-06-01003Amjevita351(k) BiosimilarDiscLicensed2016-09-23
2020-05-01001Amjevita351(k) BiosimilarRxLicensed2016-09-23
2020-05-01002Amjevita351(k) BiosimilarRxLicensed2016-09-23
2020-05-01003Amjevita351(k) BiosimilarRxLicensed2016-09-23
2020-02-01001Amjevita351(k) BiosimilarMarketedLicensed2016-09-23
2020-02-01002Amjevita351(k) BiosimilarMarketedLicensed2016-09-23
2020-02-01003Amjevita351(k) BiosimilarMarketedLicensed2016-09-23