BLA number
761340
FDA Purple Book product · Interchangeable
Epysqli
eculizumab-aagh
Epysqli, BLA 761340, is listed in the FDA Purple Book as a 351(k) interchangeable biosimilar. This page consolidates 1 exact FDA presentation row, and FDA names Soliris 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) InterchangeableBLA 761340RxLicensed Samsung Bioepis Co., Ltd.
Approved
Jul 19, 2024
License type
351(k) Interchangeable
Marketing
Rx
Listed patents
0
Epysqli (eculizumab-aagh) is a Interchangeable referencing eculizumab, licensed under a 351(k) BLA in 2024; the Purple Book lists Samsung Bioepis Co., Ltd. as the BLA applicant, not necessarily the manufacturer or commercial supplier. Its interchangeable biosimilar designation may permit pharmacy-level substitution for the reference product without prescriber intervention, subject to state law; it is not a superiority claim.
Sourced from the FDA Purple Book · verified Sep 21, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(k) interchangeable biosimilar
Applicant
Samsung Bioepis Co., Ltd.
Applicant is not automatically the physical manufacturer.
Presentations
1
Exact FDA presentation rows under this BLA.
Approval
Jul 19, 2024
Reference product
Soliris
Epysqli is an FDA-designated interchangeable biosimilar.
Epysqli is a 351(k) biosimilar of Soliris and carries an interchangeability designation.
Substitution boundary
An interchangeable designation may permit pharmacy-level substitution for the reference product without prescriber intervention, depending on state pharmacy law; it is not a claim of clinical superiority.
Key dates
Licensure & exclusivity
Approval
Approval date of this BLA submission.
Jul 19, 2024
2 yr 3 mo ago
Today
Pharmaceutical detail
FDA product record
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
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 | 300MG/30ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | 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
Epysqli names Soliris 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 Soliris
Reference-family comparison
| Product | Designation | BLA | Approved | Presentation | Marketing |
|---|---|---|---|---|---|
| Soliriseculizumab | 351(a) name-matched reference candidate | 125166 | Mar 16, 2007 | 300MG/30ML (10MG/ML) · Intravenous | Rx |
| Epysqlieculizumab-aagh | 351(k) interchangeable biosimilar | 761340 | Jul 19, 2024 | 300MG/30ML (10MG/ML) · Intravenous | 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
1 exact FDA presentation row is consolidated under this BLA rather than split across duplicate pages.
Administration fields
The loaded rows list Intravenous and Injection; these are regulatory presentation fields, not dosing instructions.
Applicant boundary
Samsung Bioepis Co., Ltd. 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
Epysqli is an FDA-designated interchangeable biosimilar. 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 Sep 21, 2026FDA release · August 2026
- monthly-downloadMonthly download · Sep 21, 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
- v6Sep 21, 2026
- v5Aug 11, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Epysqli: 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.
