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.