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..

Purple Book reference family · 351(a) biologic

eculizumab (Soliris)

eculizumab is an FDA-licensed reference biologic from Alexion Pharmaceuticals, Inc., with 2 approved follow-on biologics.

351(a) biologicBLA 125166 Alexion Pharmaceuticals, Inc.

Biosimilars

Interchangeables

Listed patents

Reference approved

2007

Reference product

Originator biologic

351(a)BLA 125166

Soliris eculizumab

Alexion Pharmaceuticals, Inc.

View full reference-product record

Approved: Mar 16, 2007
Marketing: Rx
Center: CDER
Patents: None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for eculizumab from the RCSB Protein Data Bank (PDB 5I5K).

3D molecular structure of eculizumab (PDB entry 5I5K)

Interactive biological assembly from PDB entry 5I5K. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.

Open in RCSB viewer PDB 5I5K details

Exclusivity & patent cliffs

Protection horizon

Reference approval
Approval date of the reference eculizumab product.
Mar 16, 2007
19 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 28, 2032
in 5 yr 6 mo

Biosimilars & interchangeables for eculizumab

Follow-on biologics

Biosimilars and interchangeable biosimilars 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

eculizumab: frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for eculizumab.

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