Purple Book product · Biosimilar 351(k)

Filkri

filgrastim-laha

351(k) BiosimilarBLA 761027RxLicensed Accord BioPharma Inc.

View filgrastim family Label PDF Open on FDA Purple Book

Jan 15, 2026

Approved

Biosimilar 351(k)

License type

Marketing

None

Listed patents

Filkri (filgrastim-laha) is a Biosimilar 351(k) referencing filgrastim, licensed under a 351(k) BLA in 2026 and marketed by Accord BioPharma Inc..

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

Key dates

Approval
Approval date of this BLA submission.
Jan 15, 2026
6 mo ago
Today

Pharmaceutical detail

Strength

300MCG/0.5ML

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

2105

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of filgrastim (Neupogen)

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

v6Jul 02, 2026
v5Jul 02, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026
v1Jul 02, 2026

Frequently asked questions

Is Filkri a biosimilar?

Yes. Filkri is a Biosimilar 351(k) referencing filgrastim, licensed under a 351(k) BLA.

Is Filkri interchangeable?

Filkri is a 351(k) biosimilar but does not carry an interchangeability designation in the Purple Book, so pharmacy-level substitution depends on state law.

What is Filkri's BLA number?

Filkri is licensed under BLA 761027, held by Accord BioPharma Inc..

When was Filkri approved by the FDA?

Filkri was approved by the FDA on Jan 15, 2026.

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