Purple Book product · Reference 351(a)

OMISIRGE

omidubicel-onlv

351(a)BLA 125738RxLicensed Gamida Cell Ltd.

View omidubicel-onlv family Label PDF Open on FDA Purple Book

Apr 17, 2023

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

OMISIRGE (omidubicel-onlv) is Gamida Cell Ltd.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2023. No biosimilars referencing OMISIRGE 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 17, 1930
97 yr 8 mo ago
Approval
Approval date of this BLA submission.
Apr 17, 2023
3 yr 4 mo ago
Today

Pharmaceutical detail

Strength

>4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol; >8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so

Dosage form

For Injection

Route

Intravenous

Presentation

Bag

Center

CBER

License number

2223

Product number

001

Submission type

Original

Supplement number

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.

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 OMISIRGE have approved biosimilars?

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

What is OMISIRGE's BLA number?

OMISIRGE is licensed under BLA 125738, held by Gamida Cell Ltd..

When was OMISIRGE approved by the FDA?

OMISIRGE was approved by the FDA on Apr 17, 2023.

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