Infliximab BS Nichiiko / AYUMI
Infliximab biosimilar developed by Nichi-Iko Pharmaceutical (with Ayumi Pharmaceutical). Reference product Remicade.
Brands by market: Infliximab BS Nichiiko and AYUMI (Japan) · Commercial partner or holder: Nichi-Iko Pharmaceutical (with Ayumi Pharmaceutical)
FDAnot listed
EMAnot listed
PMDASep 2017approved
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
PMDA
Japan · Infliximab BS Nichiiko / AYUMI
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Infliximab BS Nichiiko / AYUMI
Holder or applicant
Nichi-Iko Pharmaceutical; Ayumi Pharmaceutical
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2017
Indications as licensed
RA, psoriasis, Crohn’s disease, UC
Presentations
100 mg vial
Note
Infliximab Biosimilar 2.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDASep 2017Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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