The NHI Drug Price Listing and Launch of Adalimumab Biosimilar in Japan
This material is an English translation of the press release issued on November 25, 2021 in Japanese, andthe Japanese release is given priority regarding content and interpretation.
November 25, 2021
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, CEO: Kiyonori Karasawa,
hereinafter: AYUMI) announced that Adalimumab BS MA (adalimumab biosimilar, Development code: LBAL)
has been launched in Japan as the NHI (National Health Insurance) Drug Price has been listed today.
Adalimumab BS MA is an adalimumab biosimilar which Mochida has developed in Japan. Including the first80mg syringe preparation of adalimumab biosimilar in Japan, all types of preparation are available for selfinjection. Adalimumab BS MA has been launched as the first adalimumab biosimilar which contains same
concentration of the active ingredient as Humira® currently distributed in Japan.
Based on a collaboration agreement between Mochida and AYUMI, Adalimumab BS MA is supplied to AYUMI
by Mochida and distributed and promoted by AYUMI in Japan. For the indications in gastroenterology field,Mochida will also promote Adalimumab BS MA. Mochida and AYUMI are also collaborating in thecommercialization of Etanercept BS MA which has been launched in May 2018.
Mochida and AYUMI believe that Adalimumab BS MA will contribute to improving the Quality of Life and toreducing the financial burden of patients.

【References】
Generic Name:

Adalimumab (genetical recombination) [Adalimumab Biosimilar 3]

Approval Date:

March 23, 2021

NHI Drug Price Listing
Date
Launch Date:

November 25, 2021:

November 25, 2021

Manufacturer / Distributor:

Mochida Pharmaceutical Co., Ltd.

Distributor:

AYUMI Pharmaceutical Corporation

Brand Name and NHIDrug Price:

Ingredients and Contents:

Adalimumab BS Subcutaneous Injection 20 mg Syringe 0.2 mL MA
20,604 Yen
Adalimumab BS Subcutaneous Injection 40 mg Syringe 0.4 mL MA
39,913 Yen
Adalimumab BS Subcutaneous Injection 80 mg Syringe 0.8 mL MA
77,392 Yen
Adalimumab BS Subcutaneous Injection 40 mg Pen 0.4 mL MA
40,056 Yen
Injection solution
Adalimumab (genetical recombination) [Adalimumab Biosimilar 3]
20 mg/0.2 mL solution in a single-dose prefilled syringe
Adalimumab (genetical recombination) [Adalimumab Biosimilar 3]
40 mg/0.4 mL solution in a single-dose prefilled syringe
Adalimumab (genetical recombination) [Adalimumab Biosimilar 3]
80 mg/0.8 mL solution in a single-dose prefilled syringe
Adalimumab (genetical recombination) [Adalimumab Biosimilar 3]
40 mg/0.4 mL solution in a single-dose prefilled pen

Indication:

Adalimumab BS Subcutaneous Injection 20 mg Syringe 0.2 mL MA
Adalimumab BS Subcutaneous Injection 40 mg Syringe 0.4 mL MA
Adalimumab BS Subcutaneous Injection 40 mg Pen 0.4 mL MA

The following disease which does not show sufficient response to theexisting therapies:
Polyarticular Juvenile Idiopathic Arthritis
Adalimumab BS Subcutaneous Injection 40 mg Syringe 0.4 mL MA
Adalimumab BS Subcutaneous Injection 80 mg Syringe 0.8 mL MA
Adalimumab BS Subcutaneous Injection 40 mg Pen 0.4 mL MA

Rheumatoid Arthritis (including inhibition of progression of structural jointdamage)The following diseases which do not show sufficient response to theexisting therapies:
Plaque Psoriasis, Psoriatic Arthritis, Pustular Psoriasis
Ankylosing Spondylitis
Intestinal Behçet’s Disease
Remission induction and maintenance therapy for moderately or severelyactive Crohn's Disease (limited in case of inadequate response to existingtherapies)
Therapy for moderately or severely Ulcerative Colitis (limited in case ofinadequate response to existing therapies)

Dosage andAdministration:

Rheumatoid arthritis
Usually, to adults, 40 mg of Adalimumab (genetical recombination)[Adalimumab Biosimilar 3] is administered by subcutaneous injection, once
every other week. When its effect is insufficient, the dosage can be increased
up to 80 mg at a time.
Plaque Psoriasis, Psoriatic Arthritis, Pustular Psoriasis,
Usually, to adults, 80 mg of Adalimumab (genetical recombination)[Adalimumab Biosimilar 3] is administered by subcutaneous injection as
initial dose, followed by 40 mg subcutaneously, once every other week.
When its effect is insufficient, the dosage can be increased up to 80 mg at atime.
Ankylosing Spondylitis
Usually, to adults, 40 mg of Adalimumab (genetical recombination)[Adalimumab Biosimilar 3] is administered by subcutaneous injection, once
every other week. When its effect is insufficient, the dosage can be increased
up to 80 mg at a time.
Polyarticular Juvenile Idiopathic Arthritis
Usually, for patients with body weight of 15 kg to less than 30 kg, 20 mg of
Adalimumab (genetical recombination) [Adalimumab Biosimilar 3] isadministered by subcutaneous injection once every other week. For patientswith the body weight of more than 30 kg, 40 mg is administered bysubcutaneous injection once every other week.
Intestinal Behcet’s Disease
Usually, to adults, 160 mg of Adalimumab (genetical recombination)[Adalimumab Biosimilar 3] is administered by subcutaneous injection as
initial dose, followed by 80 mg subcutaneously two weeks after the initialdose. After 4 weeks or later from the initial dose, 40 mg is administered by
subcutaneous injection once every other week.
Crohn's Disease
Usually, to adults, 160 mg of Adalimumab (genetical recombination)[Adalimumab Biosimilar 3] is administered by subcutaneous injection as
initial dose, followed by 80 mg subcutaneously two weeks after initial dose.
After four weeks or later from the initial dose, 40 mg is administered bysubcutaneous injection once every other week. When its effect is reduced,
the dosage can be increased up to 80 mg at a time.

Package:

Ulcerative Colitis
Usually, to adults, 160 mg of Adalimumab (genetical recombination)[Adalimumab Biosimilar 3] is administered by subcutaneous injection as
initial dose, followed by 80 mg subcutaneously two weeks after initial dose.
After four weeks or later from the initial dose, 40 mg is administered bysubcutaneous injection once every other week.
One prefilled syringe with 29 gauge fixed needle