Infliximab biosimilars
An antibody that blocks TNF, used in bowel disease, arthritis and psoriasis, and the first antibody biosimilar approved in Europe and the United States.
About infliximab
Infliximab is an antibody that neutralises TNF, a signalling protein behind the inflammation in Crohn's disease, ulcerative colitis, rheumatoid arthritis and psoriasis. It is part mouse, part human in origin, and was one of the first antibodies to reach patients.
It binds TNF both in the blood and on the surface of cells, and the second action is thought to matter in bowel disease. That is why regulators originally asked for comparative data in bowel disease as well as arthritis.
It is an infusion into a vein, given at the start of treatment and then every eight weeks. One biosimilar, from Celltrion, also comes as an injection under the skin, approved in Europe and registered in the UAE.
Crohn's disease and ulcerative colitis in adults and children, rheumatoid arthritis, spondylitis, psoriatic arthritis and plaque psoriasis.
Immune reactions to infliximab are common and can cause loss of effect, so comparing them is a central part of any biosimilar programme. A large Norwegian study in which patients switched from the original to a biosimilar shaped European thinking on interchangeability for all biologics.
The reference product is Remicade, from Johnson & Johnson. Its European patent expired in 2015 and biosimilars took most of the market in several countries within a few years.
Infliximab is the molecule on which the rules for antibody biosimilars were written. Europe approved the first one in 2013 and the United States in 2016. The market has since matured, with four US products and three in Europe. India has one domestic maker, Reliance, alongside imports.
Clinical details are summarised from the reference product's prescribing information. Approval dates, numbers and presentations are in the tables below, each with its source.
Competitive outlook
- Todayseven infliximab biosimilars are approved in at least one of the seven markets.
- Nearest to marketCMAB008 has reached phase 3, the last trial before a filing.
- If all of them arriveThe approved count would rise from seven to eight.
22 published switching studies with infliximab biosimilars, and where evidence is still missing.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| FDA | Inflectra | CELLTRION, Inc. | Apr 2016 | 125544 | Biosimilar | Approved | S001, S016 |
| FDA | Renflexis | Samsung Bioepis Co., Ltd. | Apr 2017 | 761054 | Biosimilar | Approved | S001, S016 |
| FDA | Ixifi | Pfizer Ireland Pharmaceuticals Unlimited Company | Dec 2017 | 761072 | Biosimilar | Approved | S001, S016 |
| FDA | Avsola | Amgen Inc. | Dec 2019 | 761086 | Biosimilar | Approved | S001, S016 |
| EMA | Remsima | Celltrion Healthcare Hungary Kft. | Sep 2013 | EMEA/H/C/002576 | Approved | S017 | |
| EMA | Inflectra | Pfizer Europe MA EEIG | Sep 2013 | EMEA/H/C/002778 | Withdrawn | S017 | |
| EMA | Flixabi | Samsung Bioepis NL B.V. | May 2016 | EMEA/H/C/004020 | Approved | S017 | |
| EMA | Zessly | Sandoz GmbH | May 2018 | EMEA/H/C/004647 | Approved | S017 | |
| MHRA | Flixabi | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Inflectra | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Remsima | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Zessly | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Infliximab BS NK | Celltrion Healthcare Japan (marketed by Nippon Kayaku) | Jul 2014 | not published | Approved | S020 | |
| PMDA | Infliximab BS Nichiiko / AYUMI | Nichi-Iko Pharmaceutical; Ayumi Pharmaceutical | Sep 2017 | not published | Approved | S020 | |
| PMDA | Infliximab BS [Pfizer] | Pfizer Japan | Jul 2018 | not published | Approved | S020 | |
| HC | Remdantry | Celltrion INC. | Jan 2014 | DIN 02419475 | Approved | S022 | |
| HC | Remsima | Celltrion INC. | Jan 2014 | DIN 02419483 | Withdrawn | S022 | |
| HC | Renflexis | Samsung Bioepis CO., LTD | Dec 2017 | DIN 02470373 | Approved | S022 | |
| HC | Avsola | Amgen Canada INC | Mar 2020 | DIN 02496933 | Approved | S022 | |
| HC | Remsima SC | Celltrion INC. | Jan 2021 | DIN 02511584 | Approved | S022 | |
| HC | Ixifi | Pfizer Canada ULC | Dec 2021 | DIN 02523191 | Approved | S022 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Mar 2014 | MF-61/2014 | Approved | S014 | |
| CDSCO | Biocad India (INN only) | Biocad India Pvt Ltd | Dec 2019 | Import permission | Approved | S013 | |
| CDSCO | Pfizer (INN only) | Pfizer Limited | Sep 2021 | MP/BIO/21/000080 | Approved | S012 | |
| EDE | Remsima | Hikma Pharmaceuticals, Jordan (for Celltrion) | Jun 2017 | not published | Registered | S018 | |
| EDE | Renflexis | Samsung Bioepis NL B.V. | Oct 2021 | not published | Registered | S018 |
Last checked Sep 2026. US interchangeability designations are listed in full on the interchangeable biosimilars page. CDSCO lists permissions by firm and INN, not brand. PMDA's list and the UAE directory do not publish application numbers; Canadian dates are the first approval or market date recorded in the Drug Product Database.
Regulatory pathway by market
Requirements for an infliximab biosimilar under the guidance in force in September 2026.
| FDA, United States | EMA, European Union | MHRA, United Kingdom | PMDA, Japan | Health Canada | CDSCO, India | EDE, UAE | |
|---|---|---|---|---|---|---|---|
| Legal pathway | Section 351(k) of the Public Health Service Act (BPCIA 2009) | Article 10(4) of Directive 2001/83/EC; centralised procedure is mandatory for biotechnology products | UK marketing authorisation from MHRA. EU approvals in force at the end of 2020 became Great Britain licences automatically; new products since 2021 are approved through reliance on EMA or FDA decisions, and from 2024 through the International Recognition Procedure. Northern Ireland follows EU licences | MHLW approval on PMDA review under the Guideline for Ensuring Quality, Safety and Efficacy of Biosimilars (2009, revised 2020), with Q&A updates in 2024 and 2026 | Notice of Compliance under the Food and Drug Regulations as a biosimilar biologic drug, assessed under Health Canada's guidance on biosimilars (2016, revised 2022 and 2026) | Guidelines on Similar Biologics (CDSCO and DBT, 2016, in force); revised draft published May 2025 | Registration through the Emirates Drug Establishment; the public directory does not distinguish biosimilars from other biologicals |
| Reference product | US-licensed reference; a non-US comparator may be used with analytical and PK bridging | EU-authorised reference; a non-EEA comparator may be used with bridging data | Reference biologic authorised in the UK, or an EU-authorised version with bridging data | The original biopharmaceutical approved in Japan; foreign-sourced reference accepted with bridging since the 2020 revision | Reference biologic drug authorised in Canada, or a non-Canadian version of it with bridging data | Product licensed in India, or if not, one licensed in an ICH country, with justification | Not stated in the public directory; registration relies on assessment by reference regulators |
| Comparative clinical study | Draft guidance (October 2025): comparative analytical assessment plus a PK similarity study and immunogenicity assessment; a comparative efficacy study is generally not needed | Reflection paper adopted March 2026: a comparative efficacy trial can be waived when analytical and PK comparability is sufficient | Follows the EU guideline; MHRA's 2021 biosimilar guidance states that a comparative efficacy trial is generally not needed where analytical and pharmacokinetic comparability is shown | Comparative PK study and, in principle, a comparative efficacy study; the May 2026 early consideration sets out when the efficacy study can be omitted, and Japanese patient data are no longer required in every case (2025) | Comparative structural and functional studies, PK and, where warranted, PD equivalence; the 2026 revision reduces the expectation of comparative efficacy trials in line with FDA and EMA | Comparative PK/PD study and a comparative safety and efficacy study are generally expected, followed by a post-marketing study | Assessed on the dossier accepted by the reference regulator |
| Interchangeability | A separate designation permitting pharmacy-level substitution; switching studies generally not required under the June 2024 draft | EMA and HMA statement (September 2022): EU biosimilars are interchangeable with their reference; substitution rules are set by each member state | No designation; MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by the prescriber and by NHS commissioning | Not defined; prescribing by brand, with pharmacist substitution not automatic | No federal designation; substitution and mandatory switching policies are set by each province, several of which have required switching since 2019 | Not defined in the guidelines | Not defined |
| Naming | INN plus a four-letter suffix | INN, identical to the reference; brand name and batch recorded for pharmacovigilance | Brand name with the non-proprietary name; licence numbers PL, PLGB or PLNI | INN followed by BS (biosimilar), strength, form and the company name in quotation marks, with a biosimilar number in the non-proprietary name | Non-proprietary name identical to the reference, with brand name and DIN as identifiers | INN with the brand name | Brand name as registered |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs; MHRA guidance on the licensing of biosimilar products (2021).
EvySaif prepares the comparative evidence plan and the regional dossier strategy for infliximab programmes. Regulatory strategy consulting
Presentations and concentration
100 mg lyophilised powder per vial, reconstituted to 10 mg/mL for infusion. Remsima SC is 120 mg/mL in pre-filled syringes and pens.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Remsima / Inflectra CT-P13 | 100 mg vial | see SmPC | 100 mg vial; 100 mg vial; 120 mg pen; 40 mg/mL concentrate | 100 mg vial | 100 mg; 120 mg | 100 mg lyophilised vial | 100 mg vial (2017); 120 mg/mL SC syringe and pen (2022) |
| Renflexis / Flixabi SB2 | 100 mg vial | see SmPC | 100 mg vial | · | 100 mg | · | 100 mg vial |
| Ixifi / Zessly PF-06438179 (GP1111) | 100 mg vial | see SmPC | 100 mg vial | 100 mg vial | 100 mg | · | · |
| Avsola ABP 710 | 100 mg vial | · | · | · | 100 mg | · | · |
| Reliance Life Sciences infliximab | · | · | · | · | · | 100 mg lyophilised vial | · |
| Biocad infliximab BCD-055 | · | · | · | · | · | 100 mg lyophilised vial | · |
| Infliximab BS Nichiiko / AYUMI | · | · | · | 100 mg vial | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Celltrion | Remsima / Inflectra | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Samsung Bioepis | Renflexis / Flixabi | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Pfizer and Sandoz | Ixifi / Zessly | ✓ | ✓ | ✓ | ✓ | ✓ | · | · |
| Amgen | Avsola | ✓ | · | · | · | ✓ | · | · |
| Reliance Life Sciences | Reliance Life Sciences infliximab | · | · | · | · | · | ✓ | · |
| Biocad | Biocad infliximab | · | · | · | · | · | ✓ | · |
| Nichi-Iko Pharmaceutical (with Ayumi Pharmaceutical) | Infliximab BS Nichiiko / AYUMI | · | · | · | ✓ | · | · | · |
Entering a market where a competitor is already listed changes the evidence and pricing conversation. EvySaif's global value dossier and HTA submission work covers that side.
Products
Remsima / Inflectra
Renflexis / Flixabi
Ixifi / Zessly
Avsola
Reliance Life Sciences infliximab
Biocad infliximab
Infliximab BS Nichiiko / AYUMI
In development
ClinicalTrials.gov holds four comparative trials of three infliximab biosimilar candidates against the reference product, run by three sponsors. One of the candidates (CMAB008) has no approval yet in any of the seven markets, so they show where the next competition may come from. Trials are listed with the sponsor's own wording for status and dates.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|
| BCD-055 | Biocad | Remicade | Phase 3 | Comparative efficacy | Completed | Jan 2016 | May 2017 | Biocad infliximab | NCT02762812 |
| BCD-055 | Biocad | Remicade | Phase 3 | Comparative efficacy | Completed | Jan 2016 | Jul 2018 | Biocad infliximab | NCT02762838 |
| CMAB008 | Biomabs | Remicade | Phase 3 | Comparative efficacy | Completed | Mar 2018 | Jun 2019 | no approval in the seven markets | NCT03478111 |
| SB2 | Samsung Bioepis | Remicade | Phase 3 | Comparative efficacy | Completed | Aug 2013 | Sep 2014 | Renflexis / Flixabi | NCT01936181 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026. The full list across all molecules is on the pipeline page.
Questions
Which was the first antibody biosimilar?
Celltrion's infliximab, approved in Europe in September 2013 and in the United States in April 2016, sold as Remsima and Inflectra.
Is there an infliximab biosimilar given under the skin?
Yes, one. Celltrion's Remsima SC is approved in Europe and registered in the UAE. In the United States the same product is sold as a new biologic rather than a biosimilar.
Are infliximab biosimilars interchangeable in the United States?
No. None of the four products carries the designation.
Which infliximab biosimilars are registered in the UAE?
Celltrion's product in both infusion and under-the-skin forms, and Samsung Bioepis's product, alongside Remicade.
Why does switching to an infliximab biosimilar matter?
Because a large study in Norway showed patients could switch safely from the original to the biosimilar across all its uses, which became the evidence base for Europe's position that biosimilars are interchangeable.
Is there an infliximab biosimilar in India?
Yes. Reliance holds a manufacturing permission, and the Celltrion and Biocad products are imported.
Work with EvySaif on infliximab
Infliximab biosimilar landscape report
The register on this page as a delivered document: every approval, holder, presentation and pathway requirement across FDA, EMA, CDSCO and the Gulf, updated to the month, with the sources attached.
Request the landscape reportRegulatory gap assessment
For a developer deciding whether and where to file: a review of your analytical, PK and clinical package against what each regulator expects for infliximab, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
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)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) 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)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)S024ClinicalTrials.gov, study records (API v2, one query per molecule with the term biosimilar) Registry (sponsor-entered)
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