The NHI Drug Price Listing and Launch of Etanercept Biosimilar in Japan
This material is an English translation of the press release issued on May 30, 2018 in Japanese,and the Japanese release is given priority regarding content and interpretation.
May 30, 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 Etanercept BS「MA」 (etanerceptbiosimilar, Development code: LBEC0101) has been launched in Japan as the NHI (NationalHealth Insurance) Drug Price has been listed today.
Etanercept BS「MA」 is the first etanercept biosimilar in Japan which Mochida has developed basedon a collaboration agreement with LG Chem, Ltd., Korea. All types of preparation are available forself-injection. Based on a collaboration agreement between Mochida and AYUMI, Etanercept BS「MA」 is supplied to AYUMI by Mochida and distributed by AYUMI in Japan. As an additional
preparation, 25mg PEN is currently being developed.
Mochida and AYUMI believe that Etanercept BS「MA」 will contribute to improving the Quality of Lifeand to reducing the financial burden of patients with rheumatoid arthritis and juvenile idiopathicarthritis.

【References】
Generic Name

： Etanercept (genetical recombination) [Etanercept Biosimilar 1]

Approved Date

： January 19, 2018

NHI Drug Price Listing Date ： May 30, 2018
Launch Date

： May 30, 2018

Manufacturer/ Distributor： Mochida Pharmaceutical Co., Ltd.

Distributor： AYUMI Pharmaceutical Corporation[vial]
Brand name and NHI DrugPrice： Etanercept BS 10 mg for S.C. Inj.「MA」
Etanercept BS 25 mg for S.C. Inj.「MA」

3,697 Yen
9,099 Yen

Ingredients and Contents： Lyophilized powder for injection to be dissolved before using
Etanercept (genetical recombination) [Etanercept biosimilar 1]
10 mg / 25 mg per 1 vial

Indications： The following diseases which do not show sufficient response to theexisting therapies:
Rheumatoid arthritis (including inhibition of progression of structural
joint damage) and polyarticular-course juvenile idiopathic arthritis： 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 a time, and subcutaneously inject oncea day on two different days in the same week; or dissolve 25 to 50 mg
into 1 mL of water for injection at a time, and subcutaneously inject oncea day, once a week.
For treatment of active, polyarticular-course juvenile idiopathic arthritis:
In general, for children, inject subcutaneously 0.2 to 0.4 mg/kg ofetanercept（genetical recombination）[etanercept biosimilar1] once aday on two different days in the same week. Each dose for children
should not exceed 25 mg.
： 4 vials

Dosage andAdministration

Package[syringe/pen]
Brand name and NHI Drug
Price： Etanercept BS 25 mg Syringe 0.5mL for S.C. Inj.「MA」 9,249 Yen
Etanercept BS 50 mg Syringe 1.0mL for S.C. Inj.「MA」 18,134 Yen
Etanercept BS 50 mg PEN 1.0mL for S.C. Inj.「MA」 18,190 Yen※Etanercept BS 50 mg PEN 1.0 mL for S.C.Inj.「MA」 is a kit consisting of a syringethat comes with a fixed needle and an injector (autoinjector).

Ingredients and Contents

Indication
Dosage andAdministration

Package： Injection solution
Etanercept (genetical recombination) [Etanercept biosimilar 1]
25 mg/0.5 mL solution in a single-dose prefilled syringe
Etanercept (genetical recombination) [Etanercept biosimilar 1]
50 mg/1.0 mL solution in a single-dose prefilled syringe
Etanercept (genetical recombination) [Etanercept biosimilar 1]
50 mg/1.0 mL solution in a single-dose prefilled autoinjector： Rheumatoid arthritis (including inhibition of progression of structural jointdamage) which do not show sufficient response to the existing therapies： In general, for adults, 10 to 25 mg of etanercept（geneticalrecombination）[etanercept biosimilar1] at a time, and subcutaneously
inject once a day on two different days in the same week; or 25 to 50 mg
at a time, and subcutaneously inject once a day, once a week.
： Etanercept BS 25 mg Syringe 0.5mL for S.C. Inj.「MA」 4 syringes
Etanercept BS 50 mg Syringe 1.0mL for S.C. Inj.「MA」 2 syringes
Etanercept BS 50 mg PEN 1.0mL for S.C. Inj.「MA」 2 kits