Remsima / Inflectra
Infliximab biosimilar developed by Celltrion, development code CT-P13. Reference product Remicade.
Brands by market: Inflectra (USA); Remsima (EU, UAE); Inflectra (EU, withdrawn); Pfizer import (India) · Commercial partner or holder: Pfizer (USA, India); Hikma (UAE) · Company profile
FDAApr 2016approved
EMASep 2013authorised
MHRALicenseddate not shown
PMDAJul 2014approved
HCJan 2014approved
CDSCOSep 2021permitted
EDEJun 2017registered
Approved or registered in 7 of 7 markets
Connections
About Remsima / Inflectra
Celltrion's infliximab is the first antibody biosimilar approved anywhere in the West. Europe approved it in September 2013 under two names, Remsima and Inflectra, and the United States followed in 2016 with Inflectra, sold by Pfizer. Canada approved it in January 2014, Japan in July 2014 through Nippon Kayaku, and it is registered in the UAE through Hikma. An injection under the skin, Remsima SC, was added in Europe and Canada from 2020 and is registered in the UAE. Pfizer withdrew the European Inflectra licence in 2026, leaving Remsima as the European name. In India, Pfizer imports the product.
Status by market
FDA
United States · Inflectra
US Food and Drug AdministrationApprovedBrand
Inflectra
Holder or applicant
CELLTRION, Inc.
Pathway
351(k)
Approved
Apr 2016
Application or permission
125544
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Remicade
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 mg vial
Remarks
First monoclonal antibody biosimilar approved by FDA.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA
European Union · Remsima
European Medicines Agency and European CommissionApprovedBrand
Remsima
Holder or applicant
Celltrion Healthcare Hungary Kft.
Pathway
Centralised (Article 10(4))
Approved
Sep 2013
Application or permission
EMEA/H/C/002576
Indications as licensed
RA, Crohn's disease, UC, AS, PsA, psoriasis
Presentations
see SmPC
Remarks
First monoclonal antibody biosimilar authorised in the EU.
Source
S017 (EMA) · checked Sep 2026
EMA
European Union · Inflectra
European Medicines Agency and European CommissionWithdrawnBrand
Inflectra
Holder or applicant
Pfizer Europe MA EEIG
Pathway
Centralised (Article 10(4))
Approved
Sep 2013
Application or permission
EMEA/H/C/002778
Withdrawn
May 2026
Presentations
see SmPC
Remarks
Duplicate authorisation marketed by Pfizer; withdrawn May 2026.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Inflectra
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Inflectra
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
MHRA
United Kingdom · Remsima
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Remsima
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; 120 mg pen; 40 mg/mL concentrate
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan · Infliximab BS NK
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Infliximab BS NK
Holder or applicant
Celltrion Healthcare Japan (marketed by Nippon Kayaku)
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Jul 2014
Indications as licensed
RA, Crohn’s disease, UC
Presentations
100 mg vial
Remarks
Infliximab Biosimilar 1, the first antibody biosimilar in Japan; the CTH-branded version is discontinued.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Remdantry
Health CanadaApprovedBrand
Remdantry
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jan 2014
Application or permission
DIN 02419475
Presentations
100 mg
Source
S022 (Health Canada) · checked Sep 2026
HC
Canada · Remsima
Health CanadaWithdrawnBrand
Remsima
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jan 2014
Application or permission
DIN 02419483
Withdrawn
date not published
Presentations
100 mg
Remarks
Cancelled post-market in the Drug Product Database.
Source
S022 (Health Canada) · checked Sep 2026
HC
Canada · Remsima SC
Health CanadaApprovedBrand
Remsima SC
Holder or applicant
Celltrion INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Jan 2021
Application or permission
DIN 02511584
Presentations
120 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Pfizer Limited
Pathway
Import and marketing permission
Approved
Sep 2021
Application or permission
MP/BIO/21/000080
Indications as licensed
Crohn's disease, UC, RA, AS, PsA, psoriasis
Presentations
100 mg lyophilised vial
Remarks
Import of the Celltrion product marketed by Pfizer.
Source
S012 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates · Remsima
Emirates Drug EstablishmentRegisteredBrand
Remsima
Holder or applicant
Hikma Pharmaceuticals, Jordan (for Celltrion) · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
Jun 2017
Presentations
100 mg vial (2017); 120 mg/mL SC syringe and pen (2022)
Source
S018 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Remsima / Inflectra holds an approval, these are the other infliximab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 3 | Amgen (Avsola), Pfizer (Ixifi / Zessly), Samsung Bioepis (Renflexis / Flixabi) |
| EMA | 2 | Pfizer (Ixifi / Zessly), Samsung Bioepis (Renflexis / Flixabi) |
| MHRA | 2 | Pfizer (Ixifi / Zessly), Samsung Bioepis (Renflexis / Flixabi) |
| PMDA | 2 | Nichi-Iko Pharmaceutical (Infliximab BS Nichiiko / AYUMI), Pfizer (Ixifi / Zessly) |
| HC | 3 | Amgen (Avsola), Pfizer (Ixifi / Zessly), Samsung Bioepis (Renflexis / Flixabi) |
| CDSCO | 2 | Biocad (Biocad infliximab), Reliance Life Sciences (Reliance Life Sciences infliximab) |
| EDE | 1 | Samsung Bioepis (Renflexis / Flixabi) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Celltrion: Avtozma, Eydenzelt, Herzuma, Omlyclo, Steqeyma, Stoboclo / Osenvelt, Truxima / Blitzima, Vegzelma, Yuflyma.
Chronology
- EMASep 2013Authorised by the European Commission as Remsima
- HCJan 2014Notice of Compliance, Health Canada as Remdantry
- PMDAJul 2014Approved by MHLW as Infliximab BS NK
- FDAApr 2016Approved by FDA as Inflectra
- EDEJun 2017Registered in the UAE as Remsima
- HCJan 2021Notice of Compliance, Health Canada as Remsima SC
- CDSCOSep 2021CDSCO permission granted
- EMAMay 2026Inflectra authorisation withdrawn
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)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) 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)
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