REMICADE
REMICADE (infliximab) is a tumor necrosis factor (TNF) blocker used to treat various chronic inflammatory conditions in adult and pediatric patients. It is primarily indicated for patients with moderately to severely active Crohn’s disease or ulcerative colitis who have had an inadequate response to conventional therapy. The medication is also utilized to manage symptoms and inhibit structural damage in adults with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis.
How REMICADE Works
Infliximab neutralizes the biological activity of TNFα by binding with high affinity to both its soluble and transmembrane forms, which prevents the cytokine from binding to its receptors. This action inhibits the inflammatory cascade, including the induction of pro-inflammatory cytokines and the enhancement of leukocyte migration. By blocking these pathways, the drug reduces the production of tissue-degrading enzymes and can lead to the lysis of cells expressing transmembrane TNFα.
Details
- Status
- Prescription
- First Approved
- 1998-08-24
- Routes
- N/A
- Dosage Forms
- VIAL
REMICADE Approval History
What REMICADE Treats
8 indicationsREMICADE is approved for 8 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Crohn's Disease
- Pediatric Crohn's Disease
- Ulcerative Colitis
- Pediatric Ulcerative Colitis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Psoriatic Arthritis
- Plaque Psoriasis
REMICADE Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. ( 5.1 ) Discontinue REMICADE if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB ...
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. ( 5.1 ) Discontinue REMICADE if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting REMICADE. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including REMICADE. ( 5.2 ) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including REMICADE. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of REMICADE cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. ( 5.2 ) SERIOUS INFECTIONS Patients treated with REMICADE are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. REMICADE should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before REMICADE use and during therapy. Treatment for latent infection should be ini
REMICADE Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
REMICADE Biosimilars
4 FDA-approvedThese 4 alternatives require prescriber approval to substitute for REMICADE.
What are biosimilars? Lower-cost alternatives to REMICADE with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REMICADE FDA Label Details
ProIndications & Usage
FDA Label (PDF)REMICADE is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. Pediatric Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to...
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.