HERTFORDSHIRE, England,
PITTSBURGH and BENGALURU,
India, Feb.
16, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL)
and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced
that the U.S. Food and Drug Administration (FDA) has accepted
Mylan's Biologics License Application (BLA) for MYL-1401H, a
proposed biosimilar to
Neulasta® (pegfilgrastim), for filing
through the 351(k) pathway.
The proposed biosimilar to Neulasta is used to reduce the
duration of neutropenia (low count of neutrophils, a type of white
blood cells) and the incidence of fever associated with neutropenia
in adult patients treated with chemotherapy in certain types of
cancer.
The FDA goal date set under the Biosimilar User Fee Act (BsUFA)
is Oct. 9, 2017.
Mylan President Rajiv Malik
commented: "We're proud of the FDA acceptance of our BLA for
proposed biosimilar pegfilgrastim. This is the second BLA accepted
for review by FDA as part of the Mylan and Biocon partnership
within the past two months. The milestone builds upon the
acceptance of regulatory filings for proposed biosimilar
pegfilgrastim in Europe,
Australia, and Canada and reinforces our dedication and
commitment to establishing a global platform for this product. Once
approved, proposed biosimilar pegfilgrastim will complement Mylan's
broad oncology portfolio focused on expanding access to more
affordable treatments for multiple types of cancer."
Dr. Arun Chandavarkar, CEO and
Joint Managing Director, Biocon, said: "We are extremely
pleased with the regulatory progress of our biosimilars in the U.S.
The FDA's acceptance for review of our second BLA for a proposed
biosimilar developed by Biocon and Mylan is an outcome of our
strong R&D and manufacturing capabilities. Once approved, our proposed biosimilar
pegfilgrastim will provide a high quality alternative to branded
pegfilgrastim (Neulasta®) for cancer patients
during cytotoxic chemotherapy. It will expand our oncology
portfolio and further enable us to fulfil our promise of making
cancer-care affordable and accessible for patients across the
globe."
About the Biocon and Mylan Partnership
Biocon and Mylan are exclusive partners on a broad portfolio of
biosimilars and generic insulin analogs. The proposed biosimilar
pegfilgrastim is one of the six biologic products co-developed by
Mylan and Biocon for the global marketplace. Mylan has exclusive
commercialization rights for the proposed biosimilar pegfilgrastim
in the U.S., Canada, Japan, Australia, New
Zealand and in the European Union and European Free Trade
Association countries. Biocon has co-exclusive commercialization
rights with Mylan for the product in the rest of the world.
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 2,700 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS worldwide depend. We market our
products in more than 165 countries and territories. Our global
R&D and manufacturing platform includes more than 50
facilities, and we are one of the world's largest producers of
active pharmaceutical ingredients. Every member of our more than
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com
About Biocon
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id:
BIOCON, ISIN Id: INE376G01013) is India's largest and fully-integrated,
innovation-led biopharmaceutical company. As an emerging global
biopharmaceutical enterprise serving customers in over 100
countries, it is committed to reduce therapy costs of chronic
diseases like diabetes, cancer and autoimmune. Through innovative
products and research services it is enabling access to affordable
healthcare for patients, partners and healthcare systems across the
globe. It has successfully developed and taken a range of Novel
Biologics, Biosimilars, differentiated Small Molecules and
affordable Recombinant Human Insulin and Analogs from 'Lab to
Market'. Some of its key brands are INSUGEN® (rh-insulin), BASALOG®
(Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab) and
ALZUMAb™ (Itolizumab), a 'first in class' anti-CD6 monoclonal
antibody. It has a rich pipeline of Biosimilars and Novel Biologics
at various stages of development including Insulin Tregopil, a high
potential oral insulin.
Forward-Looking Statements: Mylan
This press release includes statements that constitute
"forward-looking statements," including with regard to the FDA goal
date; that the FDA acceptance builds upon the acceptance of
regulatory filings for proposed biosimilar pegfilgrastim in
Canada, Europe and Australia and reinforces Mylan's dedication
and commitment to establishing a global platform for the product;
that once approved, proposed biosimilar pegfilgrastim will
complement Mylan's broad oncology portfolio focused on expanding
access to more affordable treatments for all stages of cancer; and
that proposed biosimilar pegfilgrastim, once approved, will provide
a high quality alternative to branded pegfilgrastim for cancer
patients during cytotoxic chemotherapy. 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: any changes in or difficulties with Mylan's or its
partners' ability to develop, manufacture, and commercialize
products; any regulatory, legal, or other impediments to Mylan's or
its partners' ability to bring products to market; Mylan's and its
partners' ability to protect intellectual property and preserve
intellectual property rights; 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;
actions and decisions of healthcare and pharmaceutical regulators,
and changes in healthcare and pharmaceutical laws and regulations,
in the United States and abroad;
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.
Forward-Looking Statements: Biocon
Certain statements in this release concerning our future growth
prospects are forward-looking statements, which are subject to a
number of risks, uncertainties and assumptions that could cause
actual results to differ materially from those contemplated in such
forward-looking statements. Important factors that could cause
actual results to differ materially from our expectations include,
amongst others general economic and business conditions in
India, our ability to successfully
implement our strategy, our research and development efforts, our
growth and expansion plans and technological changes, changes in
the value of the Rupee and other currency changes, changes in the
Indian and international interest rates, change in laws and
regulations that apply to the Indian and global biotechnology and
pharmaceuticals industries, increasing competition in and the
conditions of the Indian biotechnology and pharmaceuticals
industries, changes in political conditions in India and changes in the foreign exchange
control regulations in India.
Neither our company, our directors, nor any of our affiliates, have
any obligation to update or otherwise revise any statements
reflecting circumstances arising after this date or to reflect the
occurrence of underlying events, even if the underlying assumptions
do not come to fruition.
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SOURCE Mylan N.V.