Tocilizumab BS MA
Tocilizumab biosimilar developed by Mochida Pharmaceutical. Reference product Actemra (RoActemra in the European Union).
Brands by market: Tocilizumab BS MA (Japan) · Commercial partner or holder: Mochida Pharmaceutical
FDAnot listed
EMAnot listed
PMDAMar 2026approved
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 · Tocilizumab BS MA
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Tocilizumab BS MA
Holder or applicant
Mochida Pharmaceutical
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2026
Indications as licensed
RA, pJIA, sJIA, Castleman’s disease, CRS, COVID-19 pneumonia; SC for RA
Presentations
80 mg, 200 mg and 400 mg IV; 162 mg syringe and auto-injector
Note
Tocilizumab 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
- PMDAMar 2026Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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