CLINICAL TRIALS PROFILE FOR INFLECTRA

Biosimilar Clinical Trials for INFLECTRA

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02452151 ↗	"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"	Unknown status	Santeon	Phase 4	2015-08-01	The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.
NCT02452151 ↗	"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"	Unknown status	Onze Lieve Vrouwe Gasthuis	Phase 4	2015-08-01	The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.
NCT02539368 ↗	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	Completed	Hospira, Inc.		2015-04-22	This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
NCT02539368 ↗	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	Completed	Hospira, now a wholly owned subsidiary of Pfizer		2015-04-22	This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
NCT02539368 ↗	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	Completed	Pfizer		2015-04-22	This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

All Clinical Trials for INFLECTRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02452151 ↗	"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"	Unknown status	Santeon	Phase 4	2015-08-01	The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.
NCT02452151 ↗	"Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"	Unknown status	Onze Lieve Vrouwe Gasthuis	Phase 4	2015-08-01	The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.
NCT02517684 ↗	Top-down Infliximab Study in Kids With Crohn's Disease	Active, not recruiting	Hospira, Inc.	Phase 4	2015-04-01	The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
NCT02517684 ↗	Top-down Infliximab Study in Kids With Crohn's Disease	Active, not recruiting	Hospira, now a wholly owned subsidiary of Pfizer	Phase 4	2015-04-01	The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
NCT02517684 ↗	Top-down Infliximab Study in Kids With Crohn's Disease	Active, not recruiting	ZonMw: The Netherlands Organisation for Health Research and Development	Phase 4	2015-04-01	The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
NCT02517684 ↗	Top-down Infliximab Study in Kids With Crohn's Disease	Active, not recruiting	Erasmus Medical Center	Phase 4	2015-04-01	The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
NCT02539368 ↗	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	Completed	Hospira, Inc.		2015-04-22	This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows: - To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

Clinical Trial Conditions for INFLECTRA

Condition Name

Condition Name for INFLECTRA
Intervention	Trials
Crohn's Disease	3
Crohn Disease	2
Psoriatic Arthritis	1
Rheumatoid Arthritis	1

Condition MeSH

Condition MeSH for INFLECTRA
Intervention	Trials
Crohn Disease	5
Colitis, Ulcerative	2
Intestinal Diseases	2
Inflammatory Bowel Diseases	2

Clinical Trial Locations for INFLECTRA

Trials by Country

Trials by Country for INFLECTRA
Location	Trials
United Kingdom	9
Spain	9
Italy	7
United States	7
Canada	7

Trials by US State

Trials by US State for INFLECTRA
Location	Trials
California	2
Wisconsin	1
Ohio	1
Indiana	1
Florida	1

Clinical Trial Progress for INFLECTRA

Clinical Trial Phase

Clinical Trial Phase for INFLECTRA
Clinical Trial Phase	Trials
Phase 4	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for INFLECTRA
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	2
Recruiting	1

Clinical Trial Sponsors for INFLECTRA

Sponsor Name

Sponsor Name for INFLECTRA
Sponsor	Trials
Hospira, Inc.	3
Hospira, now a wholly owned subsidiary of Pfizer	3
Erasmus Medical Center	2

Sponsor Type

Sponsor Type for INFLECTRA
Sponsor	Trials
Industry	8
Other	7
NIH	1

Last updated: May 5, 2026

Inflectra (Infliximab-dyyb): Clinical Trials Update, Market Analysis, and Projections

What is Inflectra and where does it sit commercially?

Inflectra (infliximab-dyyb) is a biosimilar to Remicade (infliximab) used in autoimmune inflammatory diseases. It is the biosimilar sold in the US by Pfizer’s biosimilar business (with marketing/launch history tied to Hospira/Pfizer post-acquisition; current US commercialization is Pfizer-linked). Inflectra is administered by intravenous infusion and competes primarily on biologic-naive switching, payer contracting, and margin capture versus branded reference and other infliximab biosimilars.

Key competitive set (US):

• Remicade (reference infliximab)
• Inflectra (infliximab-dyyb)
• Renflexis (infliximab-abda)
• Ixifi (infliximab-qbtx)
• Avsola (infliximab-axxq)

Why it matters for projections: infliximab’s US market has matured into a multi-biosimilar contracting environment where volume is increasingly “won” through rebate structures, formulary placement, and channel strategy rather than clinical differentiation.

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What is the clinical-trials update for Inflectra?

No complete, authoritative, current-cycle “trial updates” dataset is available in the provided information stream. A compliant clinical-trials update requires verified, dated trial-level facts (trial identifiers, status changes, results releases, enrollment updates, and endpoints) from primary registries (e.g., ClinicalTrials.gov) and/or regulatory disclosures.

Therefore, no trial-status or near-term pipeline update is presented.

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What does the infliximab biosimilar market look like for Inflectra?

Infliximab market is large and mature. Growth comes primarily from:

• Switching from reference to biosimilars (once contracts tighten, volume shifts faster)
• Maintaining share across payer cycles
• Retail infusion center and specialty channel execution
• Indication mix within approved use areas (no single biosimilar drives outcomes clinically; contracting dominates)

Biosimilar competition dynamics in infliximab:

• Price competition is constrained by biosimilar count but intense due to therapeutic equivalence and interchangeability in clinical practice.
• Manufacturers use contracting to secure volume commitments; net price outcomes drive margin, not list price.
• Patient maintenance on stable infliximab therapies reduces churn, so share gains typically depend on switching windows, payer rules, and provider formularies.

Inflectra’s relative positioning (qualitative, operational):

• Inflectra is one of the established infliximab biosimilars with broad access footprint.
• Competitive advantage is usually exercised through payer contracting depth and channel coverage rather than novel clinical mechanisms.

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Market analysis: where share is won

Share drivers that impact Inflectra specifically (and apply across the infliximab category):

1. Formulary and prior authorization rules
2. Site of infusion contracting (hospital outpatient vs community infusion)
3. Rebate and value-based contracting structures
4. Switching programs for infliximab-naive and on-reference patients
5. Physician inertia and patient stability once established

Implication for business planning: in mature biosimilar categories, the most reliable indicator of near-term performance is contracting momentum, not new clinical evidence.

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How should near-term market projections for Inflectra be modeled?

A projection requires baseline financials (US sales, regional revenue splits, unit volumes, and payer mix) plus current contracting assumptions. The provided information stream does not include those numbers. A numerical forecast without those inputs would be non-actionable.

Therefore, no quantitative revenue or unit projection is included.

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What decision-ready insights can be extracted without numeric projections?

Even without trial and financial baselines, the following are actionable for R&D or investment processes:

1) Clinical differentiation is unlikely to be the primary driver

Infliximab biosimilars are judged on:

• Demonstrated biosimilarity and comparability
• Local payer policies and interchange protocols
• Safety and effectiveness in routine care

With multiple biosimilars available, differentiation typically does not translate into large share unless coupled with superior access contracting.

2) Contracting is the dominant KPI

Inflectra performance is usually tied to:

• Payer formulary retention cycles
• Net pricing after rebates
• Preferred biosimilar status in key payers and large IDNs

3) Channel execution matters

Infusion site behavior is sticky:

• Once a site has a preferred infliximab biosimilar, switching requires administrative effort and clinical comfort.
• Direct-to-site contracting and bundled procurement can drive volume.

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Key Takeaways

• Inflectra is a mature infliximab biosimilar competing in a multi-biosimilar US environment where contracting and channel placement dominate outcomes.
• A clinical trials update is not provided because verified, dated trial-level details were not included in the available inputs.
• Quantitative market projections are not provided because baseline financial and volume assumptions were not included in the available inputs.
• For decision-making, the practical focus is payer status, infusion channel contracts, and switching mechanics rather than new clinical differentiation.

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FAQs

1) Is Inflectra considered interchangeable with Remicade?

Interchangeability is governed by regulatory designations and state-level substitution rules in the US; the biosimilar’s clinical equivalence is established through FDA biosimilarity pathways.

2) What drives Inflectra volume in the US?

Payer formulary placement, prior authorization criteria, rebate contracts, preferred biosimilar status, and infusion site contracting.

3) Are new clinical trials likely to change Inflectra share quickly?

In mature infliximab biosimilar markets, share changes usually track contracting and switching policies more than incremental clinical evidence.

4) Who are Inflectra’s main US competitors?

Renflexis, Ixifi, and Avsola, plus reference Remicade, each competing through payer and channel contracting.

5) What KPI best predicts near-term performance for biosimilars like Inflectra?

Net price after rebates and preferred formulary status across major payers and infusion channels.

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References

[1] FDA. Biosimilars and Interchangeability (Biologics). U.S. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilars
[2] FDA. Inflectra (infliximab-dyyb) Prescribing Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/