HERTFORDSHIRE, England,
PITTSBURGH and BENGALURU,
India, Nov.
8, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL)
and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced
submission of Mylan's biologics license application (BLA) for
MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and
Drug Administration (FDA) through the 351(K) pathway. This product
is a proposed biosimilar to branded trastuzumab, which is indicated
to treat certain HER2-positive breast and gastric cancers. Mylan
and Biocon believe that this has the potential to be the first
submission of a proposed biosimilar trastuzumab in the U.S.
The submitted BLA includes a comprehensive package of analytical
similarity, nonclinical and clinical data. The clinical data
consists of two pharmacokinetic studies and the HERITAGE
confirmatory efficacy and safety trial. The results of the HERITAGE
trial were presented at this year's American Society of Clinical
Oncology (ASCO) Annual Meeting and the European Society for Medical
Oncology (ESMO) Congress.
Mylan President Rajiv Malik
commented: "The FDA submission for biosimilar trastuzumab marks
Mylan's first FDA biosimilar submission from our broad portfolio of
biosimilar products in development and our product has the
opportunity to be the first biosimilar trastuzumab approved in the
U.S. This submission also is another demonstration of the strength
of the Mylan/Biocon partnership and our shared commitment to
increasing access to these critical medicines worldwide. Our
trastuzumab biosimilar is already being sold in 11 developing
markets, including India, and we
look forward to bringing the product to market in the U.S. and
Europe upon approval."
Dr Arun Chandavarkar, CEO
& Joint MD, Biocon, commented: "The submission of
our proposed biosimilar trastuzumab with the U.S. FDA is an
important milestone of Biocon and Mylan's joint global biosimilars
program and demonstrates our commitment to provide access to
high-quality and affordable biologics to patients across the globe.
Cancer patients in India and
emerging markets have benefited with our trastuzumab and this
advancement in the U.S. will enable us to enhance access to this
affordable therapy to larger patient pools."
About Biocon and Mylan Partnership
Mylan and Biocon are exclusive partners on a broad portfolio of
biosimilar and insulin products. The proposed biosimilar
trastuzumab 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 trastuzumab 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
40,000-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 analog. For more: www.biocon.com
Forward-Looking Statement: Mylan
This press release includes statements that constitute
"forward-looking statements," including with regard to regulatory
filings and submissions; bringing products to market;
approval of proposed biosimilar trastuzumab in the U.S. and
Europe; Mylan's partnership with
Biocon; and the opportunity that Mylan's and Biocon's proposed
biosimilar trastuzumab is the first biosimilar trastuzumab approved
in the U.S. 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 Statement: 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.