Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio®
(adalimumab-fkjp)
HERTFORDSHIRE, England, PITTSBURGH and TOKYO – July 9, 2020 – Mylan N.V.
(NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that theU.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp), abiosimilar to AbbVie’s Humira® (adalimumab), for the treatment of rheumatoid arthritis,
juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis,adult Crohn’s disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe
and auto-injector presentations.
Mylan President Rajiv Malik commented: “We are very pleased with FDA’s approval ofHulio, a biosimilar to the world’s top selling drug Humira, which will help bring anothertreatment option to U.S. patients living with chronic inflammatory conditions. Thisapproval represents yet another date-certain launch opportunity and demonstration of
our commitment to expand patients’ access to medicine thanks to the power of ourglobal platform, including our global reach and scale, our continued demonstration ofscientific excellence, and the benefits of strategic partnerships, such as the one we areproud to have with Fujifilm Kyowa Kirin Biologics. With one of the industry’s largest andmost diverse global biosimilars franchises, Mylan is committed to improving patient
access to this and other critically important biologic medicines as well as providing more
affordable treatment options for patients worldwide.”"The FDA approval of Hulio marks a significant milestone for both Fujifilm Kyowa Kirin
Biologics and Mylan, increasing access to affordable treatment for U.S. patients withinflammatory conditions." said Atsushi Matsumoto, Fujifilm Kyowa Kirin Biologics
President and CEO. "In cooperation with Mylan, we continue to make all efforts todeliver this high quality and affordable biosimilar throughout the world.”
In accordance with its patent license agreement with AbbVie, Mylan will be able tolaunch Hulio in the U.S. during July 2023.
The approval of Hulio was based on a comprehensive analytical, preclinical and clinicalprogram. The Phase 3 clinical study, ARABESC, conducted by Fujifilm Kyowa Kirin
Biologics, demonstrated no clinically meaningful differences in terms of safety, efficacy
and immunogenicity compared with the reference product, Humira, in rheumatoid
arthritis patients.
Mylan and Fujifilm Kyowa Kirin Biologics entered into a partnership in 2018 for thecommercialization of Hulio in Europe and Mylan has commercialized the product inseveral countries across the region. In 2019, Mylan and Fujifilm Kyowa Kirin Biologics
expanded the partnership globally. Recently, Hulio (Brand name in Japan: Adalimumab
BS “FKB”) received regulatory approval in Japan. These approvals and launches form
part of Mylan’s commitment to patients by offering one of the industry’s largest and mostdiverse global biosimilars franchises focused on the areas of oncology, immunology,endocrinology, ophthalmology and dermatology.

Humira had brand sales of approximately $14.9 billion in the U.S. for the 12 months
ending December 2019, according to AbbVie's 2019 annual report.
Hulio carries a Boxed Warning for an increased risk of serious infections leading tohospitalization or death, such as tuberculosis (TB), bacterial sepsis, invasive fungal
infections and infections due to opportunistic pathogens. Hulio should be discontinued ifa patient develops a serious infection or sepsis during treatment. Test for latent TB and
if positive, begin TB treatment before initiating Hulio. Monitor all patients for active TB
during treatment, even if the initial TB test is negative. Lymphoma and othermalignancies, some fatal, have been reported in children and adolescent patientstreated with TNF blockers including Hulio. Post-marketing cases of hepatosplenic T-cell
lymphoma have occurred in young adults with inflammatory bowel disease treated with
TNF blockers including Hulio.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards inhealthcare. Working together around the world to provide 7 billion people access to highquality medicine, we innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact the future throughpassionate global leadership. We offer a portfolio of more than 7,500 marketed products
around the world, including antiretroviral therapies on which approximately 40% ofpeople being treated for HIV/AIDS globally depend. We market our products in morethan 165 countries and territories. We are one of the world's largest producers of active
pharmaceutical ingredients. Every member of our approximately 35,000-strong
workforce is dedicated to creating better health for a better world, one person at a time.
Learn more at Mylan.com. We routinely post information that may be important toinvestors on our website at investor.mylan.com.
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 fordeveloping, manufacturing, and marketing biosimilars. Its pipeline includes anadalimumab 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 lung cancer. Fujifilm Kyowa Kirin Biologics
established Centus Biotherapeutics Ltd., a joint venture for the development andcommercialization 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 theproprietary 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, the company will develop and manufacture reliable, highquality, cost-competitive biosimilar products and commercialize these products in atimely 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
Forward-looking statements: Mylan
This press release includes statements that constitute "forward-looking statements,"
including with regard to bringing another treatment option to U.S. patients living withchronic inflammatory conditions; launching Hulio in the U.S. beginning July 2023;
product approvals; and the Company’s global platform, product franchises and strategic
partners. Because forward-looking statements inherently involve risks and uncertainties,
actual future results may differ materially from those expressed or implied by suchstatements. Factors that could cause or contribute to such differences include, but are
not limited to the potential widespread and highly uncertain impact of public healthoutbreaks, epidemics and pandemics, such as the COVID-19 pandemic; any changes in,interruptions to, or difficulties with Mylan's or its partners' ability to develop, manufacture,and commercialize products; the effect of any changes in Mylan's or its partners'
customer and supplier relationships and customer purchasing patterns; other changes
in third-party relationships; the impact of competition; changes in the economic andfinancial conditions of the businesses of Mylan or its partners; the scope, timing, andoutcome of any ongoing legal proceedings and the impact of any such proceedings onMylan's or its partners' business; any regulatory, legal, or other impediments to Mylan'sor its partners' ability to bring products to market; actions and decisions of healthcare
and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws andregulations, in the United States and abroad; Mylan's and its partners' ability to protect
intellectual property and preserve intellectual property rights; risks associated withinternational operations; other uncertainties and matters beyond the control ofmanagement; and the other risks detailed in Mylan's filings with the Securities andExchange Commission. Mylan undertakes no obligation to update these statements forrevisions or changes after the date of this release.
Contacts:
Mylan
Christine Waller (Media)
724.514.1968
Email: communications@mylan.com

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

Melissa Trombetta (Investors)
724.514.1813
Email: InvestorRelations@mylan.com

Takuro Nishijima
FUJIFILM Holdings Corporation (forFujifilm Kyowa Kirin Biologics)+81-3-6271-2000

Humira is a registered trademark of AbbVie.