Mochida obtains marketing approval for etanercept biosimilar in Japan
This material is an English translation of the press release issued on January 19, 2018 inJapanese, and the Japanese release is given priority regarding content and interpretation.
January 19, 2018
Mochida Pharmaceutical Co., Ltd.
AYUMI Pharmaceutical Corporation
Mochida Pharmaceutical Co., Ltd. (Headquarters: Tokyo, Japan, President: Naoyuki Mochida,hereinafter: Mochida) and AYUMI Pharmaceutical Corporation (Headquarters: Tokyo, Japan,President: Hikaru Ouchi, hereinafter: AYUMI) announced that Mochida obtained marketing
approval for Etanercept BS「MA」 (etanercept biosimilar, Development code: LBEC0101) from theJapanese Ministry of Health, Labour and Welfare (MHLW) on January 19.
Etanercept BS「MA」 is an etanercept biosimilar which Mochida has developed in Japan based on acollaboration agreement with LG Chem, Ltd., Korea. All types of preparation are available for selfinjection.
Based on a collaboration agreement between Mochida and AYUMI, Etanercept BS「MA」 will bedistributed by AYUMI in Japan. Expected launch date will be announced at the NHI Price Listing.
As the first etanercept biosimilar in Japan, Mochida and AYUMI believe that Etanercept BS「MA」 willcontribute to improving the Quality of Life and to reducing the financial burden of patients withrheumatoid arthritis and juvenile idiopathic arthritis.

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Summary of the marketing approval
Generic Name

： Etanercept (genetical recombination) [Etanercept Biosimilar 1]

Approved Date

： January 19, 2018

Manufactured and Distributed ： Mochida Pharmaceutical Co., Ltd.
Distributed： AYUMI Pharmaceutical Corporation[vial]
Brand name

： Etanercept BS 10 mg for S.C. Inj.「MA」
Etanercept BS 25 mg for S.C. Inj.「MA」

Indications： The following diseases which do not show sufficient responseto the existing therapies:
Rheumatoid arthritis (including inhibition of progression ofstructural joint damage) and polyarticular-course juvenile
idiopathic arthritis

Dosage and Administration： For treatment of rheumatoid arthritis: In general, for adults,
dissolve 10 to 25 mg of etanercept（genetical recombination）[etanercept biosimilar1] into 1 mL of water for injection at atime, and subcutaneously inject once a day on two differentdays in the same week; or dissolve 25 to 50 mg into 1 mL ofwater for injection at a time, and subcutaneously inject once aday, once a week.
For treatment of active, polyarticular-course juvenile idiopathic
arthritis: In general, for children, inject subcutaneously 0.2 to0.4 mg/kg of etanercept（genetical recombination）[etanercept biosimilar1] once a day on two different days in thesame week. Each dose for children should not exceed 25 mg.

[syringe/pen]
Brand name

： Etanercept BS 25 mg Syringe 0.5mL for S.C. Inj.「MA」
Etanercept BS 50 mg Syringe 1.0mL for S.C. Inj.「MA」
Etanercept BS 50 mg PEN 1.0mL for S.C. Inj.「MA」

Indication： Rheumatoid arthritis (including inhibition of progression ofstructural joint damage) which do not show sufficient responseto the existing therapies

Dosage and Administration： In general, for adults, 10 to 25 mg of etanercept（geneticalrecombination）[etanercept biosimilar1] at a time, andsubcutaneously inject once a day on two different days in thesame week; or 25 to 50 mg at a time, and subcutaneously
inject once a day, once a week.