Fujifilm Kyowa Kirin Biologics and Mylan EPD Announce Launch of “Adalimumab(Genetical Recombination) [Adalimumab Biosimilar 1]” in Japan
PITTSBURGH and TOKYO – February 15, 2021 – Fujifilm Kyowa Kirin Biologics Co., Ltd. and Mylan
EPD G.K., a company of the Viatris group, today announced that “Adalimumab (GeneticalRecombination) [Adalimumab Biosimilar 1]”, a biosimilar to AbbVie’s Humira® (Adalimumab(Genetical Recombination)), the top-selling drug in the world*, has launched in Japan. This is the firstlaunch of a biosimilar to Humira® in Japan. Mylan EPD G.K. is in charge of the commercialization.
Sun-A Kim, Country Manager, Viatris Japan said, “We are very proud to offer Adalimumab, abiosimilar to the world’s top-selling biologic medication Humira®, to patients in Japan. Today’s launchof Adalimumab, in partnership with Fujifilm Kyowa Kirin Biologics, is yet another testament to thepower of Viatris’ unique Global Healthcare Gateway® which helps partners like Fujifilm Kyowa Kirin
Biologics with strong scientific expertise to further expand patient access to more affordable
medicines in more markets around the world, including here in Japan, by leveraging Viatris’unmatched global infrastructure and regulatory expertise. Viatris strives to be a Partner of Choice TM
for companies seeking to empower more people worldwide to live healthier at every stage of life.
With one of the industry's largest and most diverse global biosimilars franchises, Viatris is committed
to improving patient access to Adalimumab and other critically important biologic medicines as wellas providing more affordable treatment options for the patient we serve.”"We are excited to be launching the first Adalimumab biosimilar in Japan, which has obtained
approvals in major market regions of the world; EU, US, Canada and Japan," said Atsushi
Matsumoto, Fujifilm Kyowa Kirin Biologics President and CEO. "We are delighted to partner withViatris, whose significant experience and expertise in regulatory commercialization supports 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 high quality
and affordable biosimilar products throughout the world."
Fujifilm Kyowa Kirin Biologics and Viatris entered into a partnership in 2018 for the commercializationof the product as Hulio® in Europe and Viatris has commercialized the product in more than 20countries across the region. In 2019, Fujifilm Kyowa Kirin Biologics and Viatris expanded thepartnership globally. Furthermore, Hulio® received market approval in the United States in 2020 andwill be marketed by Viatris in July 2023 pursuant to its patent license agreement with AbbVie.
Brand
name

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

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

Adalimumab BS
Subcutaneous Injection
20mg Syringe 0.4mL[FKB]

Genericname

Adalimumab (Genetical Recombination) [Adalimumab Biosimilar 1]

Indications Rheumatoid Arthritis (including prevention of structural
damage of joints)
The following diseases inadequately controlled byexisting therapies:
Polyarticular-course Juvenile Idiopathic Arthritis
Psoriasis Vulgaris, Arthritic Psoriasis, PustularPsoriasis, Ankylosing Spondylitis, Entero-Behcet'sDisease
Remission induction and maintenance therapy formoderately or severely active Crohn's Disease (limitedin case of inadequate response to existing therapies)
MarketApproval
June 29, 2020
dateListingdate of thestandard
drug price

Polyarticular-course
Juvenile IdiopathicArthritis

November 25, 2020

*Humira had brand sales of approximately $26.9billion globally for the 12 months ending December
2019, according to IQVIA.
About Fujifilm Kyowa Kirin Biologics
Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President: Kenji Sukeno;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 marketingbiosimilars.
By merging the technologies in advanced production, quality control and analysis which Fujifilm hasdeveloped 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 andmanufacturing, Fujifilm Kyowa Kirin Biologics creates revolutionary production processes andreduces costs for the production of biosimilars. Through this partnership, the company will develop
and manufacture reliable, high quality, cost-competitive biosimilar products and commercialize theseproducts 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

About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide tolive healthier at every stage of life. We provide access to medicines, advance sustainable operations,develop innovative solutions and leverage our collective expertise to connect more people to moreproducts and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November
2020 through the combination of Mylan and Pfizer's Upjohn business, Viatris brings together
scientific, manufacturing and distribution expertise with proven regulatory, medical and commercial
capabilities to deliver high-quality medicines to patients in more than 165 countries and territories.
Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeuticareas, spanning both non-communicable and infectious diseases, including globally recognizedbrands, complex generic and branded medicines, a growing portfolio of biosimilars and a variety ofover-the-counter consumer products. With a global workforce of approximately 45,000, Viatris isheadquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn
more at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn
and YouTube.
In Japan, Viatris Pharmaceuticals Japan Inc, Pfizer UPJ G.K., Mylan EPD G.K., and Mylan Seiyaku,Ltd. are the companies of the Viatris Group.
Contacts:Viatris/Mylan EPD

Fujifilm Kyowa Kirin Biologics

Kazumi Araki (Media)

Ryohei Kawai

Mylan EPD G.K.(Viatris Group)

Kyowa Kirin Co., Ltd (for Fujifilm Kyowa+81-3-5733-9820

Kirin Biologics)

Email: araki@viatris.com+81-3-5205-7205
Email: media@kyowa-kirin.co.jp
Takuro Nishijima
FUJIFILM Holdings Corporation (for Fujifilm
Kyowa Kirin Biologics)+81-3-6271-2000