BLA number
761082
FDA Purple Book product · Biosimilar 351(k)
Releuko
filgrastim-ayow
Releuko, BLA 761082, is listed in the FDA Purple Book as a 351(k) biosimilar. This page consolidates 4 exact FDA presentation rows, and FDA names Neupogen as its reference product. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.
351(k) BiosimilarBLA 761082 4 presentationsRxLicensed Kashiv BioSciences, LLC
Approved
Feb 25, 2022
License type
351(k) Biosimilar
Marketing
Rx
Listed patents
0
Releuko (filgrastim-ayow) is a Biosimilar 351(k) referencing filgrastim, licensed under a 351(k) BLA in 2022; the Purple Book lists Kashiv BioSciences, LLC as the BLA applicant, not necessarily the manufacturer or commercial supplier.
Sourced from the FDA Purple Book · verified Aug 11, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(k) biosimilar
Applicant
Kashiv BioSciences, LLC
Applicant is not automatically the physical manufacturer.
Presentations
4
Exact FDA presentation rows under this BLA.
Approval
Feb 25, 2022
Reference product
Neupogen
Releuko is an FDA-licensed biosimilar without an interchangeability designation in this record.
Releuko was licensed through the 351(k) pathway as biosimilar to Neupogen.
Substitution boundary
Biosimilar status alone is not an FDA interchangeability designation and does not establish automatic pharmacy substitution.
Key dates
Licensure & exclusivity
Approval
Approval date of this BLA submission.
Feb 25, 2022
4 yr 7 mo ago
Today
Strengths & presentations
4 FDA presentation rows · BLA 761082
Strength
300MCG/ML
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
2131
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
480MCG/1.6ML
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
2131
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
300MCG/0.5ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
2131
Product number
003
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
480MCG/0.8ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
2131
Product number
004
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Exact presentation matrix
One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.
| Product | Strength | Dosage form | Route | Presentation | Licensure | Marketing |
|---|---|---|---|---|---|---|
| 001 | 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Licensed | Rx |
| 002 | 480MCG/1.6ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Licensed | Rx |
| 003 | 300MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Licensed | Rx |
| 004 | 480MCG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Licensed | Rx |
Exact-source evidence coverage
Labeling & approval review
Current product label
Exact-source research required
No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.
FDA approval evidence
Exact-source research required
No independently matched exact-BLA FDA approval letter or review package is stored, so product-specific biosimilarity or switching evidence is not summarized.
Human review pending
Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 2 exact-source tasks. Labeling and approval-review claims stay unavailable until their own match gate passes.
Reference product family
Biosimilars & interchangeables
Releuko names Neupogen as its reference product. The comparison below shows locally matched BLA candidates and follow-ons; it does not invent a reference BLA number when FDA did not state one in the loaded row.
Biosimilar of Neupogen
Reference-family comparison
| Product | Designation | BLA | Approved | Presentation | Marketing |
|---|---|---|---|---|---|
| Neupogenfilgrastim | 351(a) name-matched reference candidate | 103353 | Feb 20, 1991 | 300MCG/ML · Intravenous, Subcutaneous | Rx |
| Releukofilgrastim-ayow | 351(k) biosimilar | 761082 | Feb 25, 2022 | 480MCG/1.6ML · Intravenous, Subcutaneous | Rx |
Published patents
BPCIA 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.
Practical characteristics and limits
Source-bounded interpretation
Presentation coverage
4 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.
Administration fields
The loaded rows list Intravenous, Subcutaneous and Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.
Applicant boundary
Kashiv BioSciences, LLC is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.
Regulatory comparison
Releuko is an FDA-licensed biosimilar without an interchangeability designation in this record. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.
Source provenance
FDA Purple Book data
Source kind · Monthly download
Checked Aug 11, 2026FDA release · June 2026
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
What this record does not establish
- Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
- The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
- Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
- A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
- Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.
Change history
Record versions
- v5Aug 11, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Releuko: frequently asked questions
Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.
Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
