Ustekinumab BS F
Ustekinumab biosimilar developed by Fuji Pharma. Reference product Stelara.
Brands by market: Ustekinumab BS F (Japan) · Commercial partner or holder: Fuji Pharma
FDAnot listed
EMAnot listed
PMDASep 2023approved
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 F
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Ustekinumab BS F
Holder or applicant
Fuji Pharma
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2023
Indications as licensed
Plaque psoriasis, psoriatic arthritis
Presentations
45 mg syringe; 90 mg syringe (2026)
Note
Ustekinumab Biosimilar 1, the first in Japan.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDASep 2023Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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