Ustekinumab BS YD
Ustekinumab biosimilar developed by Yoshindo. Reference product Stelara.
Brands by market: Ustekinumab BS YD (Japan) · Commercial partner or holder: Yoshindo · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDADec 2024approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Ustekinumab BS YD
Ustekinumab BS YD is Yoshindo's ustekinumab, the second approved in Japan, in December 2024. Yoshindo is a Japanese company that also markets Lupin's etanercept, though it has not named the source of its ustekinumab.
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 YD
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Ustekinumab BS YD
Holder or applicant
Yoshindo
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Dec 2024
Indications as licensed
Plaque psoriasis, psoriatic arthritis
Presentations
45 mg syringe
Remarks
Ustekinumab 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 Ustekinumab BS YD 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), Nipro (Ustekinumab BS Nipro) |
Chronology
- PMDADec 2024Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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