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.

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).

Clinical Trial Conditions for REMICADE

Condition Name

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

Condition MeSH

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

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 Market Analysis and Financial Projection

Last updated: April 25, 2026

Remicade (infliximab): clinical-trial update, market analysis, and forward projection

What is the current clinical-trial and evidence landscape for Remicade?

Remicade (infliximab) is an anti-TNF monoclonal antibody with a mature clinical evidence base in multiple immune-mediated diseases. As of the most recent publicly indexed trial records available in major trial registries, the active portfolio is dominated by (1) new or updated indications, (2) comparative regimen studies, and (3) post-marketing/real-world linked studies rather than large, de novo Phase 3 programs.

Trial activity snapshot (public registries)

The following high-level pattern describes the currently visible clinical activity for infliximab branded as Remicade across major registries:

• Registrational Phase 3: limited or absent in the newest cycles compared with earlier eras for primary indications.
• Late-stage / bridging: studies focused on subpopulations, pediatric cohorts, or regimen modifications.
• Observational / registries: ongoing patient registries and comparative effectiveness work that track outcomes under routine care.
• Safety and immunogenicity: continued monitoring around anti-drug antibodies, infusion reactions, infection risk, and pregnancy outcomes.

Where Remicade’s clinical evidence remains the core commercial support

Remicade’s commercial durability is tied to established efficacy and long-term safety experience across:

• Rheumatoid arthritis
• Crohn’s disease
• Ulcerative colitis
• Ankylosing spondylitis
• Psoriatic arthritis
• Plaque psoriasis
• Pediatric indications including pediatric Crohn’s disease and pediatric ulcerative colitis

These indications anchor the current market pull, with new clinical work typically optimizing positioning (line-of-therapy placement, switching patterns, and dosing/regimen refinements) rather than resetting the efficacy profile.

How is the Remicade market structured today (sales drivers, competition, and channel)?

Commercial structure by therapeutic category

Infliximab sits in the anti-TNF class within immune-mediated inflammatory diseases. Remicade competes against:

• Other biologics in anti-TNF (notably biosimilars)
• Non-TNF biologics and small molecules (IL-12/23, IL-23, IL-17, integrin pathway, JAK inhibitors, CTLA-4, anti-IL-1 in selected indications depending on geography and label)
• Adjacent monoclonal antibodies across the same patient segments (especially in IBD and RA)

Biosimilar impact is the dominant market variable

For mature biologics, the principal demand-shaping factors are price and formulary placement driven by biosimilar uptake. Remicade faces structural pressure in major markets where infliximab biosimilars have market share and payer coverage has tightened.

A key business implication:

• Net price and share dynamics now depend on switching (prescriber and payer) and tender/contract structures, not on efficacy differentiation.

Head-to-head brand competition

Within infliximab:

• Remicade is a reference product competing with infliximab biosimilars in many geographies. Outside infliximab:
• In IBD, competitors include agents targeting IL-12/23 (ustekinumab), IL-23 (risankizumab, guselkumab, etc.), integrin pathway (vedolizumab), and TNF-adjacent or different mechanisms.
• In RA and other arthritis indications, the field includes IL-6 pathway agents, JAK inhibitors, CTLA-4 (abatacept), anti-CD20 (in some pathways), and other cytokine axes depending on line-of-therapy.

What do the latest market metrics imply for Remicade’s trajectory?

Public market commentary and payer behavior point to the same core trajectory typical of reference biologics post biosimilar entry: revenue declines as volume shifts to lower-priced biosimilars and as payers enforce step therapy or preferred contracting.

Market progression drivers (mechanics that move the curve)

1. Biosimilar substitution

   • Increased switching from reference infliximab to approved infliximab biosimilars.
   • Tender pricing and pharmacy benefit management (PBM) dynamics in US commercial and Medicare parts where applicable.

2. Formulary narrowing and line-of-therapy

   • Coverage policies that limit the use of reference brands after biosimilar adoption.
   • Treatment pathways that steer first biologic choice toward preferred agents.

3. Patient continuity effects

   • Some patients remain stable on the reference product due to established response, physician comfort, or low immunogenicity history.
   • Over time, discontinuation rates and payer pressure erode that base.

4. Indication mix

   • IBD often has more intensive biologic use and switching; RA tends to have structured treatment algorithms and similar payer controls.
   • Pediatric use can slow switching in some settings, but contracting drives eventual substitution.

How does patent and exclusivity status shape Remicade’s outlook?

Remicade is no longer under broad primary biologic exclusivity in most major markets. The business impact is persistent:

• Reference-product sales decline as biosimilars hold coverage.
• R&D investment shifts toward next-generation assets, new formulations, or line extensions rather than defending the reference molecule’s patent estate.

While enforcement and exclusivity details vary by jurisdiction and timeline, the net effect for investment and planning is consistent: infliximab reference brand economics increasingly behave like a mature commodity in biologics terms.

Market analysis: scenario-based projection for Remicade (5-year view)

The projections below reflect standard reference biologic dynamics under ongoing biosimilar competition. Because annual sales baselines by region and payer are not provided in the source set in this workspace, the model uses index-based scenarios rather than exact revenue numbers.

Projection framework

Assume baseline = 100 for the most recent year of Remicade sales level (global or your target geography baseline). Then apply scenario-specific year-over-year (YoY) decline due to biosimilar uptake.

Scenario table (index, not currency)

Year	Base case (index)	Conservative (index)	Accelerated decline (index)
Baseline (Year 0)	100	100	100
Year 1	88	92	82
Year 2	80	85	72
Year 3	73	79	64
Year 4	67	74	58
Year 5	61	69	52

Interpretation for decision-makers

• Base case: reference infliximab continues to lose share to biosimilars, with a steady decline that gradually slows as the category saturates and physician switching stabilizes.
• Conservative: slower erosion due to higher continuity in stable patients and more mixed payer behavior across regions.
• Accelerated decline: faster substitution due to more aggressive contracting, stronger PBM formulary controls, and broader switching programs.

Sensitivity levers (what most changes the curve)

• Contracting intensity (number of payers that prefer biosimilars and enforcement strength)
• Switching protocols (automatic substitution vs physician-directed switching)
• Safety-driven persistence (patients with low anti-drug antibody rates may resist switching)
• Mechanism shift in IBD (IL-23 and other classes can divert biologic-naïve demand away from anti-TNF entirely)

How will clinical evidence likely affect Remicade’s market position (not demand creation)?

Clinical evidence is less likely to re-expand demand for Remicade in the next 3-5 years because the molecule’s efficacy is already established in labels. The clinical work that still matters commercially tends to influence:

• Persistence: maintaining response in continuing patients
• Switch success: evidence on outcomes when switching from reference to biosimilars (and within anti-TNF)
• Safety perception: ongoing safety data and infection risk management protocols
• Pediatric continuity: labeling and real-world experience influencing physician comfort with continuity or switching

Competition outlook: what matters most for Remicade in the next cycle?

Competitive gravity inside infliximab

• Biosimilar dominance: coverage and price define the competitive outcome more than clinical nuance.
• Reference-brand switching pressure: once payers lock in preferred biosimilars, prescribers face lower room for reference continuation.

Competitive gravity across mechanisms

In IBD and arthritis:

• Patients often move across mechanisms when response is incomplete or when tolerability issues arise.
• Anti-TNF remains a core option, but newer pathways can capture subsegments, especially in biologic-naïve treatment preferences depending on guideline adoption and payer policies.

Key Takeaways

• Remicade’s current clinical footprint is mostly mature evidence plus incremental late-stage and observational work that supports persistence and safety management, not major demand expansion.
• Market trajectory is dominated by infliximab biosimilar substitution and formulary contracting, which reduce reference-brand share and net price.
• A practical 5-year outlook under typical biosimilar competition is continued decline for the Remicade reference brand, with scenario outcomes ranging from roughly 31% decline (conservative) to 48% decline (accelerated) from baseline by Year 5 (index-based).

FAQs

1) Is Remicade still used as a first-line biologic in major indications?
In practice, first biologic selection is increasingly driven by payer preference and patient history; Remicade remains clinically used, but preferred contracting often shifts initial and subsequent anti-TNF selection toward biosimilars or other mechanisms depending on geography and line-of-therapy.

2) What is the biggest commercial risk to Remicade’s reference brand?
Infliximab biosimilar uptake tied to PBM/formulary contracting, which impacts both net price and share through switching.

3) What clinical findings could slow Remicade’s decline?
Evidence that supports higher persistence on reference product in real-world settings and safety profiles that improve confidence among prescribers and payers.

4) Does innovation in IBD mechanisms directly shrink anti-TNF demand?
It can, especially in biologic-naïve or early-line settings where treatment pathways increasingly incorporate non-anti-TNF mechanisms depending on guidelines and payer coverage.

5) How should investors model the near-term revenue curve for a reference biologic like Remicade?
Use a scenario framework driven by biosimilar market share capture and contracting intensity, with decline that is usually steepest early and then moderates as the patient base stabilizes.

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References

[1] FDA. REMICADE (infliximab) prescribing information. U.S. Food and Drug Administration.
[2] ClinicalTrials.gov. Remicade (infliximab) clinical studies (registry entries). National Library of Medicine.
[3] EMA. Remicade: EPAR and product information (if applicable to reference product documentation). European Medicines Agency.
[4] World Health Organization. ATC/DDD system: Infliximab (L04AB02) classification (for therapeutic class context).