Ustekinumab BS Nipro
Ustekinumab biosimilar developed by Nipro. Reference product Stelara.
Brands by market: Ustekinumab BS Nipro (Japan) · Commercial partner or holder: Nipro
FDAnot listed
EMAnot listed
PMDADec 2025approved
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 · 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
Note
Ustekinumab Biosimilar 4.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDADec 2025Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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