Remicade(infliximab)
Avsola, Flixabi, Inflectra, Remicade, Remsima, Renflexis, Zessly, Zymfentra (infliximab) is an antibody pharmaceutical. Infliximab was first approved as Remicade on 1998-08-24. It is used to treat ankylosing spondylitis, crohn disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis in the USA. It has been approved in Europe to treat ankylosing spondylitis, crohn disease, psoriasis, psoriatic arthritis, and rheumatoid arthritis amongst others. The pharmaceutical is active against tumor necrosis factor.
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Events Timeline
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Study first post date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Avsola, Inflectra, Remicade, Renflexis, Zymfentra (discontinued: Ixifi)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Infliximab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Zymfentra | infliximab-dyyb | Celltrion | N-761358 RX | 2023-10-20 | 2 products |
| Remicade | infliximab | Johnson & Johnson | N-103772 RX | 1998-08-24 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| avsola | Biologic Licensing Application | 2024-10-31 |
| ca22 benzoyl peroxide cleansing | OTC monograph final | 2022-12-08 |
| inflectra | Biologic Licensing Application | 2024-08-30 |
| infliximab | Biologic Licensing Application | 2025-03-11 |
| remicade | Biologic Licensing Application | 2025-03-05 |
| renflexis | Biologic Licensing Application | 2024-01-03 |
| zymfentra | Biologic Licensing Application | 2024-07-15 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
infliximab, Remicade, Janssen Biotech, Inc. | |||
| 2118-09-23 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| EJ | Subsequent claims for a defined course of therapy, e.g., epo, sodium hyaluronate, infliximab |
| J1745 | Injection, infliximab, excludes biosimilar, 10 mg |
| Q5103 | Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg |
| Q5104 | Injection, infliximab-abda, biosimilar, (renflexis), 10 mg |
| Q5109 | Injection, infliximab-qbtx, biosimilar, (ixifi), 10 mg |
| Q5121 | Injection, infliximab-axxq, biosimilar, (avsola), 10 mg |
| S9359 | Home infusion therapy, anti-tumor necrosis factor intravenous therapy; (e.g., infliximab); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem |
Clinical
Clinical Trials
781 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | 2 | 1 | 4 | 7 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | 1 | 1 | 4 | 6 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | — | 1 | 1 | 3 | 5 |
| Ulcer | D014456 | MPATH_579 | — | — | — | 1 | 1 | 2 | 4 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | 1 | 2 | 3 |
| Intestinal diseases | D007410 | — | K63.9 | — | — | — | 1 | 2 | 3 |
| Lymphoma | D008223 | — | C85.9 | — | — | — | 1 | — | 1 |
| T-cell lymphoma | D016399 | — | — | — | — | — | 1 | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 2 | — | 3 | 5 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | 2 | — | 3 | 5 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | — | — | 3 | 3 |
| Spondylitis | D013166 | — | M46.9 | — | — | — | — | 3 | 3 |
| Spondylarthritis | D025241 | — | — | — | — | — | — | 2 | 2 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 2 | 2 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | — | — | 2 | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 1 | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | — | 1 | 1 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Infliximab |
| INN | infliximab |
| Description | Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >6UGS:H,A|Infliximab (Remicade) Fab Heavy Chain
EVKLEESGGGLVQPGGSMKLSCVASGFIFSNHWMNWVRQSPEKGLEWVAEIRSKSINSATHYAESVKGRFTISRDDSKSA
VYLQMTDLRTEDTGVYYCSRNYYGSTYDYWGQGTTLTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS
WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKT
>6UGS:L,B|Infliximab (Remicade) Fab Light Chain
DILLTQSPAILSVSPGERVSFSCRASQFVGSSIHWYQQRTNGSPRLLIKYASESMSGIPSRFSGSGSGTDFTLSINTVES
EDIADYYCQQSHSWPFTFGSGTNLEVKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Target
Agency Approved
TNF
TNF
Organism
Homo sapiens
Gene name
TNF
Gene synonyms
TNFA, TNFSF2
NCBI Gene ID
Protein name
tumor necrosis factor
Protein synonyms
APC1 protein, Cachectin, TNF, macrophage-derived, TNF, monocyte-derived, TNF-a, TNF-alpha, tumor necrosis factor ligand 1F, Tumor necrosis factor ligand superfamily member 2, tumor necrosis factor-alpha, tumor necrotic factor alpha
Uniprot ID
Mouse ortholog
Tnf (21926)
tumor necrosis factor (P06804)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Renflexis – Organon
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Inflectra – Pfizer
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Flixabi – Biogen
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Remicade – Johnson & Johnson
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Remicade – Merck & Co
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Tabular view
Estimated US medical usage
Infliximab
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 422,777 documents
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Safety
Black-box Warning
Black-box warning for: Avsola, Inflectra, Infliximab, Remicade, Renflexis, Zymfentra
Adverse Events
Top Adverse Reactions
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247,091 adverse events reported
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