Purple Book product · Reference 351(a)

Gamifant

emapalumab-lzsg

351(a)BLA 761107RxLicensed Swedish Orphan Biovitrum AB (publ)

View emapalumab-lzsg family Label PDF Open on FDA Purple Book

Jun 07, 2023

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Gamifant (emapalumab-lzsg) is Swedish Orphan Biovitrum AB (publ)'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2023. No biosimilars referencing Gamifant are listed in the Purple Book yet.

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

Key dates

Approval
Approval date of this BLA submission.
Jun 07, 2023
3 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 20, 2025
8 mo ago
Today

Pharmaceutical detail

Strength

250MG/10ML (25MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1859

Product number

006

Submission type

Supplement

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.

5 additional BLA records 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 Gamifant have approved biosimilars?

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

What is Gamifant's BLA number?

Gamifant is licensed under BLA 761107, held by Swedish Orphan Biovitrum AB (publ).

When was Gamifant approved by the FDA?

Gamifant was approved by the FDA on Jun 07, 2023.

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