Purple Book product · Interchangeable
Epysqli
eculizumab-aagh
Jul 19, 2024
Approved
Interchangeable
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 19, 2024
2 yr ago
Today
Pharmaceutical detail
Strength
300MG/30ML (10MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2046
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of eculizumab (Soliris)
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 Epysqli a biosimilar?
Yes. Epysqli is a Interchangeable referencing eculizumab, licensed under a 351(k) BLA.
Is Epysqli interchangeable?
Yes. Epysqli carries an FDA interchangeability designation, so it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
What is Epysqli's BLA number?
Epysqli is licensed under BLA 761340, held by Samsung Bioepis Co., Ltd..
When was Epysqli approved by the FDA?
Epysqli was approved by the FDA on Jul 19, 2024.
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.
