HERTFORDSHIRE, England and
PITTSBURGH, Oct. 19, 2018 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced
that it has initiated the commercial launch of Hulio™, a biosimilar
to AbbVie's Humira® (adalimumab), across major markets
in Europe. The product, which is
approved for all adalimumab indications, will be available to
patients as soon as possible.
Mylan President Rajiv Malik commented: "We're proud of our
strategic partnership with Fujifilm Kyowa Kirin Biologics and the
strong collaboration of our science and technology teams to bring
Hulio to market for patients. As the cost of healthcare continues
to rise around the world, we know the important role that
biosimilars play to ensure patients can access the medicines they
need. The availability of Hulio, the fourth product in the area of
complex generics and biosimilars that Mylan is bringing to market
in Europe, will positively impact
the lives of patients in Europe
suffering from chronic diseases such as autoimmune disorders. We
look forward to continuing our leadership in bringing high quality,
more affordable biosimilar products to market around the
world."
"The availability of Hulio in Europe represents an important milestone,
signifying our commitment to building and executing on robust
scientific programs around our portfolio of biosimilar products in
development," said Dr. Yoshifumi
Torii, Fujifilm Kyowa Kirin Biologics President and CEO. "We
are delighted by our partnership with Mylan to bring this important
product to market in Europe."
Mylan and Fujifilm Kyowa Kirin Biologics partnered earlier this
year. Fujifilm Kyowa Kirin Biologics has a nonexclusive royalty
bearing license with AbbVie (Mylan has a sublicense) for the use
and sale of Hulio in European
countries.
The European Commission (EC) approved Hulio in September 2018, following the adoption of a
positive opinion by the Committee for Medicinal Products for Human
Use (CHMP), which concluded that the development program including
analytical, functional, clinical and immunogenicity data
demonstrated biosimilarity with Humira.
The EC approval of Hulio applies to all 28 European Union (EU)
member countries and European Economic Area (EEA) member states of
Norway, Iceland and Liechtenstein.
Hulio is indicated for the same indications of Humira,
including:
Adults
- Rheumatoid arthritis
- Ankylosing spondylitis
- Axial spondyloarthritis without radiographic evidence of
ankylosing spondylitis
- Psoriatic arthritis
- Psoriasis
- Hidradenitis suppurativa
- Crohn's disease
- Ulcerative colitis
- Uveitis
Children
- Polyarticular juvenile idiopathic arthritis (age 2 and
older)
- Enthesitis-related arthritis (age 6 and older)
- Plaque psoriasis (age 4 and older)
- Crohn's disease (age 6 and older)
- Hidradenitis suppurativa (age 12 and older)
- Uveitis (age 2 and older)
Humira is the world's best-selling biologic medication. It had
brand sales of approximately $4.3
billion in Europe for the
12 months ending July 31, 2018,
according to IQVIA.
About Adalimumab
Adalimumab is an injectable, biologic medication which inhibits
Tumour Necrosis Factor (TNF). This 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 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 growing
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which more than 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 Hakko Kirin Co.,
Ltd. (President and COO: Masashi
Miyamoto, hereinafter "Kyowa Hakko 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 advanced technologies in production, quality
control and analysis which Fujifilm has developed in its relentless
pursuit of innovation, with the proprietary technologies and
know-how which Kyowa Hakko 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 Hulio
being available to patients as soon as possible. These statements
are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Because such statements
inherently involve risks and uncertainties, actual future results
may differ materially from those expressed or implied by such
forward-looking statements. Factors that could cause or contribute
to such differences include, but are not limited to: success of
clinical trials and our or our partners' ability to execute on new
product opportunities; any regulatory, legal or other impediments
to our or our partners' ability to bring products to market; other
risks inherent in product development; the scope, timing, and
outcome of any ongoing legal proceedings, including government
investigations, and the impact of any such proceedings on our or
our partners' businesses; actions and decisions of healthcare and
pharmaceutical regulators, and changes in healthcare and
pharmaceutical laws and regulations, in the United States and abroad; the impact of
competition; strategies by competitors or other third parties to
delay or prevent product introductions; the effect of any changes
in our or our partners' customer and supplier relationships and
customer purchasing patterns; any other changes in third-party
relationships; changes in the economic and financial conditions of
the businesses of Mylan or its partners; 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.
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