Purple Book product · Reference 351(a)

Abecma

idecabtagene vicleucel

351(a)BLA 125736RxLicensed Celgene Corporation, a Bristol-Myers Squibb Company

View idecabtagene vicleucel family Label PDF Open on FDA Purple Book

Apr 04, 2024

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Abecma (idecabtagene vicleucel) is Celgene Corporation, a Bristol-Myers Squibb Company's FDA-licensed reference biologic, approved under a 351(a) BLA in 2024. No biosimilars referencing Abecma are listed in the Purple Book yet.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Apr 04, 1931
96 yr 8 mo ago
Approval
Approval date of this BLA submission.
Apr 04, 2024
2 yr 4 mo ago
Today

Pharmaceutical detail

Strength

300 to 510 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS

Dosage form

Suspension

Route

Intravenous

Presentation

Bag

Center

CBER

License number

2252

Product number

002

Submission type

Supplement

Supplement number

218

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

1 additional BLA record for this product (other strengths or presentations) are in the same reference family.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Abecma have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Abecma are listed in the FDA Purple Book yet.

What is Abecma's BLA number?

Abecma is licensed under BLA 125736, held by Celgene Corporation, a Bristol-Myers Squibb Company.

When was Abecma approved by the FDA?

Abecma was approved by the FDA on Apr 04, 2024.

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