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Drug ReportsInfliximab
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
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
digestive system diseasesD004066
skin and connective tissue diseasesD017437
immune system diseasesD007154
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
Zymfentrainfliximab-dyybCelltrionN-761358 RX2023-10-20
2 products
RemicadeinfliximabJohnson & JohnsonN-103772 RX1998-08-24
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
avsolaBiologic Licensing Application2025-09-08
ca22 benzoyl peroxide cleansingOTC monograph final2022-12-08
inflectraBiologic Licensing Application2025-09-10
infliximabBiologic Licensing Application2025-06-03
progest-oil-2oz-sbunapproved drug other2025-06-01
remicadeBiologic Licensing Application2025-06-03
renflexisBiologic Licensing Application2024-01-03
zymfentraBiologic Licensing Application2025-05-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
psoriatic arthritisEFO_0003778D015535L40.5
ulcerative colitisEFO_0000729D003093K51
ankylosing spondylitisEFO_0003898D013167M45
rheumatoid arthritisEFO_0000685D001172M06.9
crohn diseaseEFO_0000384D003424K50
Agency Specific
FDA
EMA
Expiration
Code
infliximab, Remicade, Janssen Biotech, Inc.
2118-09-23Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AB: Tumor necrosis factor alpha (tnf-alpha) inhibitors
— L04AB02: Infliximab
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
840 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L40———123
Rheumatoid arthritisD001172EFO_0000685M06.9——11—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic renal insufficiencyD051436—N18—12——3
Secondary hyperparathyroidismD006962EFO_1001173——12——3
Kidney diseasesD007674EFO_0003086N08——2——2
Neoplasm metastasisD009362EFO_0009708———2——2
HyperparathyroidismD006961EFO_0008506E21.3——2——2
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
Psoriatic arthritisD015535EFO_0003778L40.5————11
ArthritisD001168EFO_0005856M05-M14————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameInfliximab
INNinfliximab
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 classmonoclonal antibodies
Image (chem structure or protein)Loading
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
Identifiers
PDB4G3Y, 5VH3, 5VH4, 5VH5, 6UGS, 6UGT, 6UGU, 6UGV, 6UGW, 6UGX, 6UGY
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201581
ChEBI ID—
PubChem CID—
DrugBankDB00065
UNII IDB72HH48FLU (ChemIDplus, GSRS)
Target
Agency Approved
TNF
TNF
Organism
Homo sapiens
Gene name
TNF
Gene synonyms
TNFA, TNFSF2
NCBI Gene ID
7124
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
Q9UIV3
Mouse ortholog
Tnf (21926)
tumor necrosis factor (P06804)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Flixabi – Biogen
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Inflectra – Pfizer
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Remicade – Johnson & Johnson
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Remicade – Merck & Co
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Renflexis – Organon
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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 447,138 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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253,627 adverse events reported
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