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 · Company profile

FDAJul 2024approved

EMAMay 2023authorised

MHRALicenseddate not shown

PMDANot listed

HCNot listed

CDSCONot listed

EDENot listed

Approved or registered in 3 of 7 markets

Connections

Eculizumabmolecule Samsung Bioepisdeveloper 3 of 7markets 2trials behind it 9other products, same developer 1rival developers in its markets

About Epysqli

Epysqli is Samsung Bioepis's eculizumab, approved in Europe in May 2023, a month after Amgen's, and in the United States in July 2024, where it became interchangeable in late 2025. It is one of the few biosimilars for an ultra-rare disease.

Status by market

FDA

United States · Epysqli

US Food and Drug AdministrationApproved

Brand

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

Reference product in the Purple Book

Soliris

Marketing status (Purple Book)

Prescription, marketed

Presentations

300 mg/30 mL vial

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union · Epysqli

European Medicines Agency and European CommissionApproved

Brand

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 (EMA) · checked Sep 2026

MHRA

United Kingdom · Epysqli

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Epysqli

Holder or applicant

Not shown in the MHRA substance list

Pathway

UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)

Approved

not published

Presentations

300 mg vial

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Epysqli by development code, brand or developer. Registry data, sponsor-entered.

Candidate	Developer or sponsor	Reference product	Phase	Design	Registry status	Started	Primary completion	Registry record
SB12	Samsung Bioepis	Soliris	Phase 3	Comparative efficacy	Completed	Aug 2019	Sep 2021	NCT04058158
SB12	Samsung Bioepis	Soliris	Phase 1	Comparative PK	Completed	Nov 2018	Mar 2019	NCT03722329

Other developers in the same markets

Where Epysqli holds an approval, these are the other eculizumab biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	1	Amgen (Bkemv / Bekemv)
EMA	1	Amgen (Bkemv / Bekemv)
MHRA	1	Amgen (Bkemv / Bekemv)

Same developer, other molecules

Other biosimilars in the Atlas developed by Samsung Bioepis: Aybintio, Byooviz, Eticovo / Benepali, Hadlima / Imraldi, Ontruzant, Opuviz, Ospomyv / Xbryk / Obodence, Pyzchiva, Renflexis / Flixabi.

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)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All eculizumab biosimilars

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Data current to September 2026.