Home/Biosimilar Atlas/Infliximab/Ixifi / Zessly

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) · Company profile
FDADec 2017approved
EMAMay 2018authorised
MHRALicenseddate not shown
PMDAJul 2018approved
HCDec 2021approved
CDSCONot listed
EDENot listed
Approved or registered in 5 of 7 markets
Connections
InfliximabmoleculePfizer and Sandozdeveloper5 of 7markets0trials behind it6other products, same developer4rival developers in its markets

About Ixifi / Zessly

This infliximab was developed by Pfizer and is sold as Ixifi in the United States, approved in 2017, and by Sandoz as Zessly in Europe, approved in 2018. Pfizer never launched Ixifi in the United States, because it already sold Celltrion's Inflectra there. Japan approved it under Pfizer's name in 2018, and Canada in 2021.

Status by market

FDA

United States · Ixifi

US Food and Drug AdministrationApproved
Brand
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
Reference product in the Purple Book
Remicade
Marketing status (Purple Book)
Discontinued
Presentations
100 mg vial
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Zessly

European Medicines Agency and European CommissionApproved
Brand
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 (EMA) · checked Sep 2026
MHRA

United Kingdom · Zessly

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Zessly
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 · Infliximab BS [Pfizer]

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
Infliximab BS [Pfizer]
Holder or applicant
Pfizer Japan
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Jul 2018
Indications as licensed
RA, psoriasis, Crohn’s disease, UC
Presentations
100 mg vial
Remarks
Infliximab Biosimilar 3.
Source
S020 (PMDA) · checked Sep 2026
HC

Canada · Ixifi

Health CanadaApproved
Brand
Ixifi
Holder or applicant
Pfizer Canada ULC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Dec 2021
Application or permission
DIN 02523191
Presentations
100 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
FDA3Amgen (Avsola), Celltrion (Remsima / Inflectra), Samsung Bioepis (Renflexis / Flixabi)
EMA2Celltrion (Remsima / Inflectra), Samsung Bioepis (Renflexis / Flixabi)
MHRA2Celltrion (Remsima / Inflectra), Samsung Bioepis (Renflexis / Flixabi)
PMDA2Celltrion (Remsima / Inflectra), Nichi-Iko Pharmaceutical (Infliximab BS Nichiiko / AYUMI)
HC3Amgen (Avsola), Celltrion (Remsima / Inflectra), Samsung Bioepis (Renflexis / Flixabi)

Same developer, other molecules

Other biosimilars in the Atlas developed by Pfizer: Abrilada / Amsparity, Nivestym / Nivestim, Nyvepria, Ruxience, Trazimera, Zirabev.

Chronology

Sources

All infliximab biosimilars

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Data current to September 2026.