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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) · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDASep 2017approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets

About Infliximab BS Nichiiko / AYUMI

Infliximab BS Nichiiko is Nichi-Iko's own infliximab, approved in Japan in September 2017 as the second infliximab biosimilar there, and also sold under the name of Ayumi Pharmaceutical. Nichi-Iko is one of the few Japanese generics companies to develop its own biosimilars.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan · Infliximab BS Nichiiko / AYUMI

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
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
Remarks
Infliximab Biosimilar 2.
Source
S020 (PMDA) · checked Sep 2026
HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Infliximab BS Nichiiko / AYUMI holds an approval, these are the other infliximab biosimilars approved in that market.

MarketRivalsDevelopers (product)
PMDA2Celltrion (Remsima / Inflectra), Pfizer (Ixifi / Zessly)

Same developer, other molecules

Other biosimilars in the Atlas developed by Nichi-Iko Pharmaceutical: Bevacizumab BS Nichi-Iko.

Chronology

Sources

All infliximab biosimilars

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Data current to September 2026.