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Brands by market: Inflectra (USA); Remsima (EU, UAE); Inflectra (EU, withdrawn); Pfizer import (India) · Commercial partner or holder: Pfizer (USA, India); Hikma (UAE)
FDAApr 2016approved
EMASep 2013authorised
CDSCOSep 2021permitted
EDEJun 2017registered
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
Presentations
100 mg vial
Note
First monoclonal antibody biosimilar approved by FDA.
Source
S001, S016
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
Note
First monoclonal antibody biosimilar authorised in the EU.
Source
S017
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Withdrawn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
Note
Duplicate authorisation marketed by Pfizer; withdrawn May 2026.
Source
S017
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
Note
Import of the Celltrion product marketed by Pfizer.
Source
S012
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
Chronology
- EMASep 2013Authorised by the European Commission as Remsima
- FDAApr 2016Approved by FDA as Inflectra
- EDEJun 2017Registered in the UAE as Remsima
- 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- EMAMay 2026Inflectra authorisation withdrawn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)
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