Etanercept BS MA
Etanercept biosimilar developed by Mochida Pharmaceutical (LG Chem product), development code LBEC0101. Reference product Enbrel.
Brands by market: Etanercept BS MA (Japan) · Commercial partner or holder: Mochida Pharmaceutical (LG Chem product)
FDAnot listed
EMAnot listed
PMDAJan 2018approved
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 · Etanercept BS MA
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Etanercept BS MA
Holder or applicant
Mochida Pharmaceutical
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Jan 2018
Indications as licensed
RA, pJIA
Presentations
10 mg and 25 mg vials; 25 mg/0.5 mL and 50 mg/mL syringes; 25 mg and 50 mg pens
Note
Etanercept 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
- PMDAJan 2018Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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