Renflexis / Flixabi
Infliximab biosimilar developed by Samsung Bioepis, development code SB2. Reference product Remicade.
Brands by market: Renflexis (USA, UAE); Flixabi (EU) · Commercial partner or holder: Organon (USA); Biogen (EU)
FDAApr 2017approved
EMAMay 2016authorised
CDSCOnot listed
EDEOct 2021registered
Status by market
FDA
United States · Renflexis
US Food and Drug AdministrationApprovedBrand
Renflexis
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
Apr 2017
Application or permission
761054
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg vial
Source
S001, S016
EMA
European Union · Flixabi
European Medicines Agency and European CommissionApprovedBrand
Flixabi
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
May 2016
Application or permission
EMEA/H/C/004020
Indications as licensed
RA, Crohn's disease, UC, AS, PsA, psoriasis
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Renflexis
Emirates Drug EstablishmentRegisteredBrand
Renflexis
Holder or applicant
Samsung Bioepis NL B.V. · UAE supplier Gulf Med Medicines LLC
Pathway
Registered medical product
Registered
Oct 2021
Presentations
100 mg vial
Source
S018
Chronology
- EMAMay 2016Authorised by the European Commission as Flixabi
- FDAApr 2017Approved by FDA as Renflexis
- EDEOct 2021Registered in the UAE as Renflexis
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)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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