Home/Biosimilar Atlas/Infliximab/Renflexis / Flixabi

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) · Company profile

FDAApr 2017approved

EMAMay 2016authorised

MHRALicenseddate not shown

PMDANot listed

HCDec 2017approved

CDSCONot listed

EDEOct 2021registered

Approved or registered in 5 of 7 markets

Connections

Infliximabmolecule Samsung Bioepisdeveloper 5 of 7markets 1trial behind it 9other products, same developer 3rival developers in its markets

About Renflexis / Flixabi

Renflexis is Samsung Bioepis's infliximab, sold as Flixabi in Europe by Biogen and as Renflexis in the United States by Organon. Europe approved it in 2016 and the United States and Canada in 2017. It is registered in the UAE. It was the second infliximab biosimilar in each market, following Celltrion by three years in Europe and one in the United States.

Status by market

FDA

United States · Renflexis

US Food and Drug AdministrationApproved

Brand

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

Reference product in the Purple Book

Remicade

Marketing status (Purple Book)

Prescription, marketed

Presentations

100 mg vial

Source

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

EMA

European Union · Flixabi

European Medicines Agency and European CommissionApproved

Brand

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 (EMA) · checked Sep 2026

MHRA

United Kingdom · Flixabi

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Flixabi

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

100 mg vial

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada · Renflexis

Health CanadaApproved

Brand

Renflexis

Holder or applicant

Samsung Bioepis CO., LTD

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Dec 2017

Application or permission

DIN 02470373

Presentations

100 mg

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates · Renflexis

Emirates Drug EstablishmentRegistered

Brand

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 (UAE Emirates Drug Establishment) · checked Sep 2026

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Renflexis / Flixabi 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
SB2	Samsung Bioepis	Remicade	Phase 3	Comparative efficacy	Completed	Aug 2013	Sep 2014	NCT01936181

Other developers in the same markets

Where Renflexis / Flixabi holds an approval, these are the other infliximab biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	3	Amgen (Avsola), Celltrion (Remsima / Inflectra), Pfizer (Ixifi / Zessly)
EMA	2	Celltrion (Remsima / Inflectra), Pfizer (Ixifi / Zessly)
MHRA	2	Celltrion (Remsima / Inflectra), Pfizer (Ixifi / Zessly)
HC	3	Amgen (Avsola), Celltrion (Remsima / Inflectra), Pfizer (Ixifi / Zessly)
EDE	1	Celltrion (Remsima / Inflectra)

Same developer, other molecules

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

Chronology

EMAMay 2016Authorised by the European Commission as Flixabi
FDAApr 2017Approved by FDA as Renflexis
HCDec 2017Notice of Compliance, Health Canada 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)
S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All infliximab biosimilars

Planning infliximab biosimilar development?

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Data current to September 2026.