infliximab

Ligand id: 5004

Name: infliximab

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Classification
Compound class Antibody
Approved drug? Yes (FDA (1998), EMA (1999))
International Nonproprietary Names
INN number INN
7602 infliximab
Synonyms
cA2 | Inflectra® | Remicade® | Remsima® | SB2 | TA-650
Database Links
Specialist databases
IMGT/mAb-DB 156
Other databases
GtoPdb PubChem SID 178101701
PubChem SID 178101701
Search PubMed clinical trials infliximab
Search PubMed titles infliximab
Search PubMed titles/abstracts infliximab
Wikipedia Infliximab
Comments
Infliximab is an anti-tumour necrosis factor (TNF)α, mouse-human chimeric monoclonal antibody. It binds both soluble and transmembrane forms of TNFα but not lymphotoxin α (TNFβ).
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.
Peptide sequence analysis reveals this to be antibody cA2 in patent US5656272 [4].

Biosimilars:
In 2016 biosimilar agent CT-P13 (developed by Celltrion, also known as infliximab-dyyb; Remsima®, Inflectra®) was approved in several countries for use in all indications for which reference infliximab is approved [1-2,8]. Although the approval covers the same indicated conditions as the reference drug, it should be noted that CT-P13 is approved as a biosimilar and not as an interchangeable product.
Flixabi® (a.k.a. Renflexis®, SB2, infliximab-abda) manufactured and commercialized by Biogen in the EU, received EMA marketing authorisation in 2016, followed by FDA approval in April 2017.
Pfiizer's infliximab-qbtx (PF-06438179 [3], Ixifi®) was FDA approved in Dec 2017.
NI-071 (Nichi-Iko Pharmaceutical) has been approved in Japan (October 2017) [6], and is in Phase 3 trial (NCT02990806) in the US with a view to FDA approval.
BCD-055 (Biocad) is in Phase 3 development- see rheumatoid arthritis trial NCT02762838 as an example.
BOW015 (a.k.a. Infliximab-EPIRUS, Epirus Biopharmaceuticals) is being evaluated in phase 3 clinical trial NCT02683564 for rheumatoid arthritis.