Fujifilm Kyowa Kirin Biologics Announces Approval of “Adalimumab (GeneticalRecombination) [Adalimumab Biosimilar 1]” in JapanTOKYO, June 29, 2020 –Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that Fujifilm
Kyowa Kirin Biologics received manufacturing and marketing approval (MMA) in Japan on June
29 for “Adalimumab (Genetical Recombination) [Adalimumab Biosimilar 1]” (Product Code:FKB327).
The product is the first approved adalimumab biosimilar in Japan to AbbVie Inc's Humira®
(adalimumab) marketed most widely around the world. In Japan, Fujifilm Kyowa Kirin Biologics
is the marketing authorization holder and Mylan EPD G.K. will be in charge of thecommercialization of the product.
Fujifilm Kyowa Kirin Biologics entered into a partnership with Mylan in 2018 for thecommercialization of the biosimilar adalimumab in Europe and expand it globally in 2019. To
date, Mylan has commercialized the product as Hulio® in over 20 countries across Europe.
Fujifilm Kyowa Kirin Biologics will continue to work obtaining marketing approvals in othercountries around the world.
"We are proud to be a leader by providing the first Adalimumab biosimilar in Japan,"said Atsushi Matsumoto, Fujifilm Kyowa Kirin Biologics President and CEO. "It is ourcommitment to contribute to increasing the treatment options for the patients with inflammatory
conditions as well as saving healthcare costs. We continue to make all efforts to deliver the highquality and affordable biosimilar throughout the world.”“Adalimumab (Genetical Recombination) [Adalimumab Biosimilar 1]” is indicated as follows:
Brand name

Generic nameIndications

Adalimumab BS Subcutaneous
Injection 40mg Syringe 0.8mL [FKB]
Adalimumab BS Subcutaneous
Injection 40mg Pen 0.8mL [FKB]

Adalimumab BS SubcutaneousInjection 20mg Syringe 0.4mL [FKB]

Adalimumab (Genetical Recombination) [Adalimumab Biosimilar 1]

Rheumatoid Arthritis, Psoriasis
Vulgaris, Arthritic Psoriasis, PustularPsoriasis, Ankylosing Spondylitis,
Entero-Behcet's Disease, Crohn'sDisease, Polyarticular-course
Juvenile Idiopathic Arthritis

Polyarticular-course Juvenile
Idiopathic Arthritis

Humira is the world's best-selling medication. It had brand sales of approximately $26.9 billion
globally for the 12 months ending Dec. 31, 2019, according to IQVIA.
About Adalimumab
Adalimumab is an injectable, biologic medication which inhibits Tumour Necrosis Factor (TNF).
TNF can cause inflammation in autoimmune diseases such as rheumatoid arthritis, plaquepsoriasis, Crohn’s disease and ulcerative colitis. By specifically binding to TNF, adalimumab
blocks its activity, thereby reducing inflammation and other disease symptoms.
About Fujifilm Kyowa Kirin Biologics
Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President: KenjiSukeno; hereinafter “Fujifilm”) and Kyowa Kirin Co., Ltd. (President and CEO: Masashi
Miyamoto, hereinafter “Kyowa Kirin”) on March 27, 2012 as a company for developing,manufacturing, and marketing biosimilars. Its pipeline includes an adalimumab biosimilar Hulio®
and a biosimilar of the anti-VEGF humanized monoclonal antibody bevacizumab (Product Code:FKB238), a drug used to treat a range of cancers including colorectal and non-small cell lungcancer. Fujifilm Kyowa Kirin Biologics established Centus Biotherapeutics Ltd., a joint venturefor the development and commercialization of FKB238 with AstraZeneca plc.
By merging the technologies in advanced production, quality control and analysis which Fujifilm
has developed over many years through its photographic film business, with the proprietary
technologies and know-how which Kyowa Kirin has accumulated through its biopharmaceutical
R&D and manufacturing, Fujifilm Kyowa Kirin Biologics creates revolutionary production
processes and reduces costs for the production of biosimilars. Through this partnership, thecompany will develop and manufacture reliable, high quality, cost-competitive biosimilar
products and commercialize these products in a timely manner. With this strategy, Fujifilm
Kyowa Kirin Biologics aims to hold a leading position in the expanding biosimilar market.
You can learn more about the business at: fujifilmkyowakirin-biologics.com
Contacts:
Fujifilm Kyowa Kirin Biologics
Ryohei Kawai
Kyowa Kirin Co., Ltd (for Fujifilm Kyowa Kirin Biologics)+81-3-5205-7205
Email: media@kyowa-kirin.co.jp
Takuro Nishijima
Fujifilm Corporation (for Fujifilm Kyowa Kirin Biologics)+81-3-6271-2000