Ixifi / Zessly
Infliximab biosimilar developed by Pfizer and Sandoz, development code PF-06438179 (GP1111). Reference product Remicade.
Brands by market: Ixifi (USA); Zessly (EU) · Commercial partner or holder: Pfizer (USA); Sandoz (EU)
FDADec 2017approved
EMAMay 2018authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Ixifi
US Food and Drug AdministrationApprovedBrand
Ixifi
Holder or applicant
Pfizer Ireland Pharmaceuticals Unlimited Company
Pathway
351(k)
Approved
Dec 2017
Application or permission
761072
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg vial
Source
S001, S016
EMA
European Union · Zessly
European Medicines Agency and European CommissionApprovedBrand
Zessly
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
May 2018
Application or permission
EMEA/H/C/004647
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
Not listed by EDE.
Chronology
- FDADec 2017Approved by FDA as Ixifi
- EMAMay 2018Authorised by the European Commission as Zessly
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)
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