RxBNSoliris
eculizumab
1 reference · 2 interchangeable
Reference Product
Soliris
eculizumab
351(a) Reference Product (Approval Date 16-Mar-2007)
ApplicantAlexion Pharmaceuticals, Inc.
BLA125166
RouteIntravenous
Presentation
Single-Dose Vial
Soliris
eculizumab
351(a) Reference Product (Approval Date 16-Mar-2007)
ApplicantAlexion Pharmaceuticals, Inc.
BLA125166
·RouteIntravenous
Presentation
Single-Dose Vial
Interchangeable Biosimilars
Bkemv
eculizumab-aeeb
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 28-May-2024)
ApplicantAmgen Inc.
BLA761333
RouteIntravenous
Presentation
Single-Dose Vial
Bkemv
eculizumab-aeeb
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 28-May-2024)
ApplicantAmgen Inc.
BLA761333
·RouteIntravenous
Presentation
Single-Dose Vial
Epysqli
eculizumab-aagh
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 28-Nov-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761340
RouteIntravenous
Presentation
Single-Dose Vial
Epysqli
eculizumab-aagh
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 28-Nov-2025)
ApplicantSamsung Bioepis Co., Ltd.
BLA761340
·RouteIntravenous
Presentation
Single-Dose Vial
Biosimilars (not interchangeable)
No non-interchangeable biosimilars in this group.