Epysqli
Eculizumab biosimilar developed by Samsung Bioepis, development code SB12. Reference product Soliris.
Brands by market: Epysqli (USA, EU) · Commercial partner or holder: Samsung Bioepis
FDAJul 2024approved
EMAMay 2023authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Epysqli
US Food and Drug AdministrationApprovedBrand
Epysqli
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
Jul 2024
Application or permission
761340
Licence type
351(k) interchangeable, designated Nov 2025
Presentations
300 mg/30 mL vial
Source
S001, S016
EMA
European Union · Epysqli
European Medicines Agency and European CommissionApprovedBrand
Epysqli
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
May 2023
Application or permission
EMEA/H/C/006036
Indications as licensed
PNH, aHUS, gMG
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAMay 2023Authorised by the European Commission as Epysqli
- FDAJul 2024Approved by FDA as Epysqli
- FDANov 2025Epysqli designated interchangeable
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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