Purple Book product · Biosimilar 351(k)
Nivestym
filgrastim-aafi
Jul 20, 2018
Approved
Biosimilar 351(k)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Jul 20, 2018
8 yr 1 mo ago
Today
Pharmaceutical detail
Strength
480MCG/0.8ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
1974
Product number
004
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar 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
- 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
Is Nivestym a biosimilar?
Yes. Nivestym is a Biosimilar 351(k) referencing filgrastim, licensed under a 351(k) BLA.
Is Nivestym interchangeable?
Nivestym 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 Nivestym's BLA number?
Nivestym is licensed under BLA 761080, held by Hospira Inc., a Pfizer Company.
When was Nivestym approved by the FDA?
Nivestym was approved by the FDA on Jul 20, 2018.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
