HERTFORDSHIRE, England
and PITTSBURGH and TOKYO,
July 9, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ:
MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced
that the U.S. Food and Drug Administration (FDA) has approved
Hulio® (adalimumab-fkjp), a biosimilar 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 of Hulio, a biosimilar to the world's top
selling drug Humira, which will help bring another treatment option
to U.S. patients living with chronic inflammatory conditions. This
approval represents yet another date-certain launch opportunity and
demonstration of our commitment to expand patients' access to
medicine thanks to the power of our global platform, including our
global reach and scale, our continued demonstration of scientific
excellence, and the benefits of strategic partnerships, such as the
one we are proud to have with Fujifilm Kyowa Kirin Biologics. With
one of the industry's largest and most 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 with inflammatory
conditions." said Atsushi Matsumoto, Fujifilm Kyowa Kirin
Biologics President and CEO. "In cooperation with Mylan, we
continue to make all efforts to deliver this high
quality and affordable biosimilar throughout the world."
In accordance with its patent license agreement with AbbVie,
Mylan will be able to launch Hulio in the U.S. during July 2023.
The approval of Hulio was based on a comprehensive analytical,
preclinical and clinical program. 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 the commercialization of Hulio in
Europe and Mylan has
commercialized the product in several 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 most diverse 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 to hospitalization or death, such as
tuberculosis (TB), bacterial sepsis, invasive fungal infections and
infections due to opportunistic pathogens. Hulio should be
discontinued if a 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 other malignancies, some fatal, have been reported in
children and adolescent patients treated 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 in healthcare. Working together
around the world to provide 7 billion people access to high quality
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 through passionate global leadership. We offer a
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which approximately 40% of
people being treated for HIV/AIDS globally depend. We market our
products in more than 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 to investors 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 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 lung cancer. Fujifilm Kyowa Kirin Biologics
established Centus Biotherapeutics Ltd., a joint venture for 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, the company 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
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 with chronic
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 such statements.
Factors that could cause or contribute to such differences include,
but are not limited to the potential widespread and highly
uncertain impact of public health outbreaks, 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 and financial conditions of the businesses
of Mylan or its partners; the scope, timing, and outcome of any
ongoing legal proceedings and the impact of any such proceedings on
Mylan's or its partners' business; any regulatory, legal, or other
impediments to Mylan's or its partners' ability to bring products
to market; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United States
and abroad; Mylan's and its partners' ability to protect
intellectual property and preserve intellectual property rights;
risks associated with international operations; other uncertainties
and matters beyond the control of management; and the other risks
detailed in Mylan's filings with the Securities and Exchange
Commission. Mylan undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
Humira is a registered trademark of AbbVie.
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SOURCE Mylan N.V.
