Adalimumab BS MA
Adalimumab biosimilar developed by Mochida Pharmaceutical. Reference product Humira.
Brands by market: Adalimumab BS MA (Japan) · Commercial partner or holder: Mochida Pharmaceutical
FDAnot listed
EMAnot listed
PMDAMar 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 MA
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Adalimumab BS MA
Holder or applicant
Mochida Pharmaceutical
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2021
Indications as licensed
RA, pJIA, psoriasis, PsA, pustular psoriasis, AS, intestinal Behcet’s, Crohn’s disease, UC
Presentations
20 mg/0.2 mL, 40 mg/0.4 mL, 80 mg/0.8 mL syringes; 40 mg/0.4 mL pen
Note
Adalimumab Biosimilar 3; 100 mg/mL presentations.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDAMar 2021Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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