Adalimumab BS Daiichi Sankyo
Adalimumab biosimilar developed by Daiichi Sankyo. Reference product Humira.
Brands by market: Adalimumab BS Daiichi Sankyo (Japan) · Commercial partner or holder: Daiichi Sankyo
FDAnot listed
EMAnot listed
PMDAJan 2021approved
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 · Adalimumab BS Daiichi Sankyo
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Adalimumab BS Daiichi Sankyo
Holder or applicant
Daiichi Sankyo
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Jan 2021
Indications as licensed
RA, psoriasis, PsA, pustular psoriasis, AS, pJIA, intestinal Behcet’s
Presentations
20 mg/0.4 mL and 40 mg/0.8 mL syringes; 40 mg/0.8 mL pen
Note
Adalimumab Biosimilar 2.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDAJan 2021Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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