eculizumab (Soliris)
eculizumab is an FDA-licensed reference biologic from Alexion Pharmaceuticals, Inc., with 2 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
2
Interchangeables
0
Listed patents
2007
Reference approved
Reference product
Soliris eculizumab
Alexion Pharmaceuticals, Inc.
- Approved
- Mar 16, 2007
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for eculizumab from the RCSB Protein Data Bank (PDB 5I5K).
Interactive biological assembly from PDB entry 5I5K. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for eculizumab, in chronological order.
Reference approval
Approval date of the reference eculizumab product.
19 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 10 mo
Biosimilars & interchangeables for eculizumab
2 FDA-licensed follow-on biologics referencing eculizumab.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Bkemv | eculizumab-aeeb | Amgen Inc. | Interchangeable | 761333 | May 28, 2024 |
| Epysqli | eculizumab-aagh | Samsung Bioepis Co., Ltd. | Interchangeable | 761340 | Jul 19, 2024 |
Frequently asked questions
What biosimilars are approved for eculizumab (Soliris)?
The FDA Purple Book lists 2 approved follow-on biologics referencing eculizumab: Bkemv and Epysqli. Of these, 2 are interchangeable biosimilars and 0 are 351(k) biosimilars.
Is there an interchangeable biosimilar for eculizumab?
Yes. Bkemv and Epysqli are approved as interchangeable biosimilars for eculizumab, meaning they may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
Who makes eculizumab biosimilars?
Companies with FDA-approved follow-on biologics referencing eculizumab include Amgen Inc. and Samsung Bioepis Co., Ltd..
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.