CLINICAL TRIALS PROFILE FOR REMICADE

Biosimilar Clinical Trials for REMICADE

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02148640 ↗	The NOR-SWITCH Study	Completed	South-Eastern Norway Regional Health Authority	Phase 4	2014-10-01	The purpose of this study is to assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis
NCT02148640 ↗	The NOR-SWITCH Study	Completed	Diakonhjemmet Hospital	Phase 4	2014-10-01	The purpose of this study is to assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis
NCT02359903 ↗	Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis	Completed	Biocad	Phase 1	2015-02-01	ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis.
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

All Clinical Trials for REMICADE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00029042 ↗	Infliximab to Treat Children With Juvenile Rheumatoid Arthritis	Terminated	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	2002-01-01	This study will determine whether a stepwise increase of the drug infliximab (Remicade® (Registered Trademark)) controls juvenile rheumatoid arthritis more effectively than a fixed dose. It will look at the safety and effectiveness of increasing the dose to a maximum of 15mg/kg body weight per dose, examining the drug's effect on bone and cartilage, and whether it can improve abnormal growth, metabolism and hormones. Infliximab is approved for treating adults with rheumatoid arthritis and Crohn's disease. Children between 4 and 17 years of age with active juvenile rheumatoid arthritis who do not respond adequately to standard therapy may be eligible for this study. Participants will receive nine infusions of infliximab during this 62-week study. The drug is given intravenously (IV, into a vein) over 2 hours. The first three infusions will be at a dose of 5 mg/kg of body weight. Children who improve on this regimen will receive another 6 infusions at the same dose. Children who do not significantly improve on 5 mg/kg at the end of 6 weeks (the third infusion) may continue with phase 2 of the study, in which they will be randomly assigned to receive either: 1) 6 additional doses of the drug at 5 mg/kg per dose, or 2) a gradually increased dose to a maximum of 15 mg/kg. In addition, all children will continue to take methotrexate at the same dose as when they entered the study. Participants will visit the NIH Clinical Center 12 times (about every 8 weeks) during the study for the following tests and procedures: - History and physical examination, including a complete joint exam - Puberty assessment - breast development in girls, testicle size in boys, and pubic hair - Height and weight measurements Children will have imaging studies (x-rays, MRI and Dexa scan) at the beginning and end of the study and will collect a 24-hour urine sample before each infliximab infusion. Patients may elect to have an endocrine evaluation. This involves Clinical Center hospitalizations for 1-1/2 days on visits 1, 4 and 12. Small amounts of blood will be drawn every 20 minutes (through an indwelling catheter to avoid multiple needle sticks) for 8 hours while the child sleeps. The blood will be examined for the normal rhythm of growth hormone and other substances in the body and how they are affected by arthritis. Participants will complete a questionnaire once a year for 2 years to provide information on their health status and any problems that might be related to the study drug.
NCT00033891 ↗	Infliximab (Remicade ) to Treat Dermatomyositis and Polymyositis	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	2002-04-10	This study will examine whether infliximab (Remicade ) is safe and effective for the treatment of dermatomyositis and polymyositis. Infliximab blocks the effect of a protein called tumor necrosis factor (TNF), which is associated with harmful inflammation in many diseases. Patients 18 years of age and older with active dermatomyositis or polymyositis that does not respond adequately to treatment with methotrexate and corticosteroids may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests, chest x-ray, pulmonary function test, skin test for tuberculosis, HIV test, electromyography (described below), manual muscle testing, and functional assessments. Magnetic resonance imaging (described below) will be done to assess the degree and location of inflammation in the involved limbs. An electrocardiogram and echocardiogram will be done if recent ones are not available. Patients who qualify for the study will be asked to undergo two muscle biopsies (surgical removal and analysis of small pieces of muscle tissue), one before initiation of treatment and another on the 16th week . Participants will be randomly assigned to receive either 3 mg/kg body weight of infliximab or a placebo (inactive substance) by infusion through a vein over 2 hours. The infusions will be given at the beginning of the treatment period (week 0) and at weeks 2, 6 and 14. At week 16, strength will be assessed by manual muscle testing. Patients who improved with treatment will continue with the same infusion dose on weeks 18, 22, 30, and 38. Those who do not improve will be assigned by random allocation to receive either 5 mg/kg body weight or 10/mg/kg body weight of infliximab on weeks 18, 22, 30 and 38. Those who did not improve who were previously on the placebo infusion will receive an extra dose of either 5 mg/kg or 10 mg/kg body weight of infliximab on week 16, while those patients who were previously on 3 mg/kg body weight of infliximab who failed to meet the improvement criteria will receive an infusion containing no medication on week 16. Patients will be admitted to the hospital for infusions at weeks 0, 14 and 38; the rest will be given on an outpatient basis. After the 38th week, all infusions will be stopped and patients will be assessed on the 40th week. Participants will undergo some or all of the following tests and evaluations during treatment: - Blood tests every week to look for antibodies seen with muscle inflammation. Some of the blood samples will be stored for later testing, including genetic studies to find genetic differences related to inflammation. - Skin test for tuberculosis - Chest x-rays at the beginning of the study (if a recent one is not available) and again at weeks 16 and 40 to look for active infection, detect signs of past exposure or infection with diseases such as tuberculosis, and assess the presence of lung disease that might be related to the myositis. - MRI (usually of the legs) at the beginning of the study and again at weeks 16 and 40 to measure disease activity and extent of muscle involvement. This will also give an idea of the response to treatment. This test uses a magnetic field and radio waves to produce images of body tissues. During the procedure the patient lies on a bed surrounded by a metal cylinder (the scanner). - Muscle biopsy at the beginning of the study to diagnose muscle inflammation and again at week 16 to evaluate the response to treatment. - Electromyography if the patient has not had an EMG previously. For this test, small needles are inserted into the muscle to assess the electrical activity of the muscle - HIV test Patients whose disease worsen with treatment or who develop serious drug-related side effects will be taken off the study and referred back to their primary care physician for further therapy. Patients who improve will be referred back to their primary physician at the end of the study for possible continued treatment. Participants will be asked to return for follow-up visits every 6 weeks for a total of 30 weeks to monitor long-term effects of the drug
NCT00036374 ↗	A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis	Completed	Centocor, Inc.	Phase 3	2001-10-01	The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).
NCT00036387 ↗	A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.	Completed	Centocor, Inc.	Phase 3	1969-12-31	The purpose of this study is to evaluate the safety and effectiveness of Infliximab (Remicade) in patients with Rheumatoid Arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce the pain of rheumatoid arthritis.
NCT00036439 ↗	A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis	Completed	Centocor, Inc.	Phase 3	2002-02-01	The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis.
NCT00051623 ↗	A Study of the Safety and Effectiveness of Infliximab for the Treatment of Psoriatic Arthritis	Completed	Centocor, Inc.	Phase 3	2003-05-01	The purpose of this study is to determine if Infliximab is safe and effective in the treatment of psoriatic arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Clinical Trial Conditions for REMICADE

Condition Name

Condition Name for REMICADE
Intervention	Trials
Rheumatoid Arthritis	26
Crohn's Disease	16
Ulcerative Colitis	12
Crohn Disease	10

Condition MeSH

Condition MeSH for REMICADE
Intervention	Trials
Arthritis	42
Arthritis, Rheumatoid	37
Crohn Disease	29
Colitis, Ulcerative	14

Clinical Trial Locations for REMICADE

Trials by Country

Trials by Country for REMICADE
Location	Trials
United States	401
Canada	62
United Kingdom	21
Spain	13
Belgium	11

Trials by US State

Trials by US State for REMICADE
Location	Trials
California	22
Ohio	19
Texas	17
New York	17
Maryland	17

Clinical Trial Progress for REMICADE

Clinical Trial Phase

Clinical Trial Phase for REMICADE
Clinical Trial Phase	Trials
Phase 4	32
Phase 3	45
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for REMICADE
Clinical Trial Phase	Trials
Completed	94
Terminated	19
Recruiting	11

Clinical Trial Sponsors for REMICADE

Sponsor Name

Sponsor Name for REMICADE
Sponsor	Trials
Centocor, Inc.	31
Merck Sharp & Dohme Corp.	16
Emory University	5

Sponsor Type

Sponsor Type for REMICADE
Sponsor	Trials
Other	142
Industry	98
NIH	17

Remicade (infliximab) clinical trials update, market analysis, and revenue projection

Last updated: July 26, 2026

Remicade (infliximab) remains the anchor anti-TNF biologic in gastroenterology, rheumatology, and dermatology, with ongoing label expansion, lifecycle formulation work, and incremental manufacturing and comparative clinical activity. Commercially, the portfolio is dominated by biosimilar competition in the US and Europe, with remaining revenue concentrated in switch-resistant patient segments, payer contracting, and indication-level demand. Revenue projections are primarily driven by biosimilar penetration rate, tender outcomes, and persistence rather than new patient growth from long-run scientific demand.

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What is the latest Remicade (infliximab) clinical trials landscape?

Answer: Trials in 2024-2026 are focused on post-marketing comparative effectiveness, real-world treatment sequencing, special populations (pediatrics, older adults, pregnancy), biomarkers and therapeutic drug monitoring, and combination/optimization strategies rather than a brand-new mechanism.

Which trial types are most active for infliximab?

1. Comparative effectiveness and treat-to-target strategies across Crohn’s disease, ulcerative colitis, rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis.
2. Real-world evidence cohorts on persistence, switch outcomes, and immunogenicity.
3. Therapeutic drug monitoring (TDM) studies tying trough concentrations and anti-drug antibodies to outcomes.
4. Safety surveillance in special populations.
5. Biosimilar interchange and switching protocols (often with endpoints like disease activity, flare rates, and antibody development).

What are the most common clinical endpoints in current infliximab studies?

• Crohn’s disease and ulcerative colitis: endoscopic remission, clinical remission, steroid-free remission, hospitalization and surgery rates
• Rheumatology: ACR responses, DAS28, BASDAI/BASFI, radiographic progression proxies, flare rates
• Dermatology: PASI-based endpoints and joint involvement measures
• Immunogenicity/safety: anti-infliximab antibody incidence, infusion reactions, infection rates, malignancy surveillance metrics

What parts of the infliximab clinical story still change the label indirectly?

• Updated safety learning from registries and pharmacovigilance
• TDM-based algorithms impacting how dosing is optimized
• Strategy trials influencing guideline uptake, which impacts prescribing patterns even without label changes

Clinical trial intelligence note: Recent “activity” around infliximab is often driven by comparative and practical strategy trials rather than first-in-class pivots, which means market impact comes through evidence adoption, not through mechanism novelty.

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Which new clinical trials and studies directly affect Remicade prescribing decisions?

Answer: Studies that quantify outcomes after switching (originator to biosimilar) and trials that validate TDM-based dose adjustments have the most immediate prescribing influence.

Switching studies and interchange evidence

• Endpoints track disease activity, time to flare, discontinuation, antibody formation, and steroid use
• Practical implications: lower clinical “friction” when switching is associated with stable outcomes, which accelerates payer-driven substitution

Therapeutic drug monitoring (TDM) trials

• Trough levels and anti-drug antibodies are used to guide proactive dose escalation or de-escalation
• Practical implications: payers and infusion centers adopt standardized TDM algorithms, which can reduce “brand loyalty” and increase substitution acceptance

Combination strategy evidence

• Optimization with immunomodulators and steroids sparing is used to reduce immunogenicity and maintain remission
• Practical implications: the originator loses less when the clinical protocol is robust, but standardized protocols still favor lowest net cost supply

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How big is the Remicade (infliximab) market and what are the key demand drivers?

Answer: Demand is concentrated in IBD and rheumatology, with growth capped in mature markets by biosimilar substitution. Remaining demand is sustained by durability, clinical familiarity, and contracting dynamics.

Primary indication demand pools

• Crohn’s disease
• Ulcerative colitis
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis / axial spondyloarthritis
• Psoriatic arthritis
• Plaque psoriasis (where applicable)

Demand drivers that keep originator share alive

• Patients who remain stable on originator therapy
• Provider and infusion-center standardization that is slow to change
• Payer contracting that sometimes preserves originator share through preferred formulary tiers or patient exemptions
• Immunogenicity histories that make switching riskier for a subset of patients

Demand drains

• Price pressure from biosimilars
• Payer-driven switching mandates
• Patient-level discontinuation or conversion after policy changes

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What is the Orange Book status of Remicade (infliximab) and what does it mean for generic entry?

Answer: Remicade is a biologic and is not evaluated through the small-molecule Orange Book “generic” framework. Exclusivity and competitive entry risks flow through the Biologics Price Competition and Innovation Act (BPCIA) pathway, biosimilar and interchangeable product pathways, and clinical interchange policies.

Key practical implication

• “Generic” entry in the Orange Book sense is not the relevant threat model for infliximab.
• The relevant threat is biosimilar entry, tendering, and switching uptake.

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When does Remicade lose exclusivity and when can biosimilars expand freely?

Answer: Remicade’s originator exclusivity has long since passed in major markets; the ongoing competitive landscape is driven by biosimilar uptake, patent-by-patent lifecycle constraints, and interchange/tender policies rather than a single remaining “cliff” exclusivity date.

What actually governs market share now

• Biosimilar label approvals (indication-by-indication)
• Tender outcomes and reimbursement rules
• Interchange guidance and payer policies on switching
• Remaining method-of-use and formulation patent estates (jurisdiction dependent) that can shape launch timing or exclusivity for specific claim sets

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What patents protect Remicade (infliximab) and how strong is the estate today?

Answer: Today’s protection is primarily lifecycle and formulation/method claim coverage rather than broad product-class protection. Practical strength is usually limited by biosimilar engineering, with key litigation risk concentrated on specific claim sets.

How the estate typically affects biosimilar launches

• If a biosimilar is forced into design-arounds or delayed by litigation, share gains slow.
• If claims are narrowed or settled, launches proceed and market shifts quickly based on price.

Litigation risk pattern

• Disputes often target dosing regimens, methods of treatment, or manufacturing/combination claims rather than the fundamental sequence itself.

Note: A complete, jurisdiction-by-jurisdiction patent table requires a specific dataset (e.g., Orange Book/BioPatent lists or EPO family mapping) that is not provided here.

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Which biosimilars compete with Remicade and how does competition affect Remicade pricing?

Answer: Competition is dominated by infliximab biosimilars (US and EU), with pricing typically compressing toward the lowest net cost and originator share shrinking unless protected by contracts or patient persistence.

Competitive dynamics that move quickly

• Hospital group purchasing organizations (GPOs) and infusion networks select preferred suppliers
• Pharmacy and therapeutics committees implement therapeutic interchange policies
• Payers apply step edits, prior authorization, or biosimilar-first requirements

What determines whether Remicade retains share despite biosimilar competition

• Tender terms including rebates and access programs
• Real-world persistence rates on originator versus biosimilar
• Provider preferences tied to patient outcomes and switching experience

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What patent litigation and settlements have shaped the infliximab biosimilar market?

Answer: Infliximab biosimilar litigation has historically centered on patent claims that can delay or restrict launch for specific biosimilar products in specific jurisdictions, with settlements typically ending with market entry and royalty or access commitments.

Typical settlement outcomes

• Biosimilar launch timing aligned to court or agreement terms
• Royalty payments or cross-licenses
• Restrictions on certain claim scopes or interchange communications

Note: A complete litigation timeline with case numbers and dates requires the underlying litigation docket mapping, which is not included in the request.

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How do clinical trial outcomes translate into market projections for Remicade?

Answer: Projections depend more on competitive adoption and persistence than on incremental clinical improvements. Trials that reduce switching risk or validate TDM protocols increase substitution acceptance and reduce originator demand.

Market translation mechanism

1. Clinical evidence supports stable outcomes after switching
2. Providers become less concerned about flare risk and antibody formation
3. Payers increase biosimilar-first policies
4. Net price pressure accelerates and originator share declines

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Remicade market projection: base case, downside, and upside

Answer: Without a dataset of current Remicade unit sales, net price, and specific geographic revenue split, precise numeric forecasting cannot be produced. The correct projection framework is substitution-driven S-curves: biosimilar penetration, persistence, and contracting determine the trajectory.

Projection framework (what to model)

• Starting share by geography and setting (hospital outpatient vs infusion centers)
• Biosimilar penetration rate (by tender cycles and payer policies)
• Persistence on biologics after switch (drug survival curves)
• Dose intensity trends tied to treat-to-target protocols
• New patient starts vs switch-driven volume migration
• Price per treated patient trend (originator price erosion vs biosimilar price ceilings)

Scenario mapping

• Downside: faster switching acceptance, broader tender adoption, and steeper net price erosion
• Base case: steady penetration with persistence-protected originator segments
• Upside: slower uptake due to patient stability, payer exceptions, or originator access programs offsetting list price decline

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How does Remicade compare with other anti-TNF biologics and IL-targeted therapies?

Answer: In mature markets, Remicade’s differentiation is largely practical (clinical familiarity, long safety history, established protocols), while competitive pressure increasingly comes from both biosimilars of infliximab and alternative mechanisms with different efficacy/safety profiles.

Key competitive pressure points

• IL-12/23, IL-23, integrin, JAK inhibitors, and IL-17 class adoption in IBD and dermatology
• Positioning based on comorbidity profile, speed of response, and steroid-sparing evidence
• Switching rules across classes influenced by payers

What matters for Remicade share

• Where clinicians can justify switching across mechanisms
• Reimbursement and guideline alignment by payer and region
• Patient tolerance, infection risk profile, and immunogenicity history

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Key Takeaways

• Remicade’s near-term clinical activity is concentrated in strategy, safety, TDM, and switching evidence rather than mechanism innovation.
• Market risk is dominated by biosimilar penetration, tendering, and payer-driven switching policies; remaining originator demand is persistence and contract-driven.
• A numerically precise revenue projection requires current sales and net pricing inputs; the correct modeling approach is substitution S-curves driven by penetration and persistence rather than trial-only growth.
• Litigation continues to matter at the margins via claim scope and launch timing in specific jurisdictions, but the core threat is established biosimilar competition.

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FAQs

1. What clinical endpoints most influence infliximab switching acceptance in IBD?
   Endoscopic remission, flare rates, steroid-free remission, time to escalation, and immunogenicity outcomes.

2. Do therapeutic drug monitoring trials increase biosimilar uptake for infliximab?
   Evidence that ties troughs and antibodies to outcomes generally supports standardized dosing algorithms, which lowers switching friction.

3. Is Remicade subject to Orange Book generic competition?
   No. It is a biologic competing through biosimilar pathways under BPCIA rather than small-molecule Orange Book generics.

4. What factors most impact Remicade net price in hospitals?
   Preferred formulary contracting, rebate structures, tender cycles, and utilization management rules.

5. Which therapeutic areas are most exposed to infliximab biosimilar substitution?
   Crohn’s disease and ulcerative colitis, followed by rheumatology indications where payer policies can mandate biosimilar-first strategies.

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References

1. U.S. Food and Drug Administration. “Biosimilar Biological Products.” FDA.gov.
2. U.S. Food and Drug Administration. “Guidance for Industry: Demonstration of Biosimilarity of a Therapeutic Protein Product to a Reference Product.” FDA.gov.
3. U.S. FDA. “Purple Book.” FDA.gov.
4. European Medicines Agency. “Biosimilar medicines.” EMA.europa.eu.