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) · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDAJan 2018approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets

About Etanercept BS MA

Etanercept BS MA is Mochida's etanercept, the first etanercept biosimilar approved in Japan, in January 2018. The product was developed by LG Chem of Korea, and Mochida sells it in Japan in vials, syringes and pens.

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 · Etanercept BS MA

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
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
Remarks
Etanercept Biosimilar 1, the first in Japan.
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 Etanercept BS MA holds an approval, these are the other etanercept biosimilars approved in that market.

MarketRivalsDevelopers (product)
PMDA1Lupin (Nepexto / Fubelv / Lupin etanercept)

Same developer, other molecules

Other biosimilars in the Atlas developed by Mochida Pharmaceutical: Adalimumab BS MA, Pegfilgrastim BS Mochida / Nipro, Teriparatide BS Mochida, Tocilizumab BS MA.

Chronology

Sources

All etanercept biosimilars

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Data current to September 2026.