Ustekinumab BS Nipro
Ustekinumab biosimilar developed by Nipro. Reference product Stelara.
Brands by market: Ustekinumab BS Nipro (Japan) · Commercial partner or holder: Nipro · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDADec 2025approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Ustekinumab BS Nipro
Ustekinumab BS Nipro is Nipro's ustekinumab, the fourth approved in Japan, in December 2025. Nipro is a Japanese medical device and pharmaceutical company and this is one of its first 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 · Ustekinumab BS Nipro
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Ustekinumab BS Nipro
Holder or applicant
Nipro
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Dec 2025
Indications as licensed
Plaque psoriasis, psoriatic arthritis
Presentations
45 mg syringe
Remarks
Ustekinumab Biosimilar 4.
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 Ustekinumab BS Nipro holds an approval, these are the other ustekinumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| PMDA | 3 | Celltrion (Steqeyma), Fuji Pharma (Ustekinumab BS F), Yoshindo (Ustekinumab BS YD) |
Chronology
- PMDADec 2025Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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