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 · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDAMar 2021approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets

About Adalimumab BS MA

Adalimumab BS MA is Mochida's adalimumab, approved in Japan in March 2021 as the third adalimumab biosimilar there. It is offered in the high-concentration form, in three strengths as a syringe and one as a pen, with a full set of Japanese indications. Mochida is a mid-sized Japanese company with several biosimilars in its range, including etanercept, teriparatide, pegfilgrastim and tocilizumab.

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 · Adalimumab BS MA

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
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
Remarks
Adalimumab Biosimilar 3; 100 mg/mL presentations.
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 Adalimumab BS MA holds an approval, these are the other adalimumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
PMDA3Celltrion (Yuflyma), Daiichi Sankyo (Adalimumab BS Daiichi Sankyo), Fujifilm Kyowa Kirin Biologics (Hulio)

Same developer, other molecules

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

Chronology

Sources

All adalimumab biosimilars

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Data current to September 2026.