HERTFORDSHIRE, England
and PITTSBURGH and BENGALURU, India, July 13,
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) Oncologic Drugs
Advisory Committee (ODAC) recommended approval of the companies'
proposed biosimilar trastuzumab. The committee voted 16-0 in
support of eligible indications of the reference product,
Herceptin®, which include HER2-positive breast cancer in the
metastatic and adjuvant settings.
Mylan President Rajiv Malik
commented: "We are pleased with ODAC's recommendation to support
the approval of Mylan's proposed biosimilar trastuzumab to increase
affordability, competition and most importantly overall access and
use. As one of the largest suppliers of cancer medicines by volume
in the U.S., Mylan is committed to serving this important patient
community. We look forward to working with FDA to further increase
access to this important treatment option for the thousands of
patients affected by HER2-positive breast cancer each year."
Biocon CEO and Joint Managing Director Dr. Arun Chandavarkar said: "We welcome ODAC's
endorsement of our biosimilar trastuzumab as it brings our
collaboration a step closer to addressing the critical needs of
cancer patients in the U.S. We now look forward to engaging with
the FDA to seek final approval in order to expand access to a
high-quality, affordable option for treating HER2-positive breast
cancers."
Data presented to ODAC included results from analytical,
nonclinical and clinical studies which demonstrated that our
proposed biosimilar trastuzumab is highly similar to Herceptin, in
line with the FDA assessment provided in the pre-meeting briefing
documents. ODAC determined that no clinically meaningful
differences exist between the biosimilar product and Herceptin in
terms of safety, purity and potency. As such, the committee
concluded that the totality of evidence supports a recommendation
for FDA approval.
FDA uses advisory committees and panels to obtain independent
expert advice on a variety of matters, including product approvals.
FDA often follows the advice of ODAC in determining whether a
product should come to market, although they are not required to
follow it.
Mylan and Biocon's proposed biosimilar trastuzumab also is under
review by regulatory authorities in Australia, Canada, Europe and several emerging markets.
About the 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 market a
growing portfolio of more than 7,500 products around the world,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world 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 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 120 countries, it is committed to reduce therapy costs of
chronic diseases like diabetes, autoimmune and cancer. 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.
Visit: www.biocon.com
Forward-Looking Statement: Mylan
This press release
includes statements that constitute "forward-looking statements,"
including with regard to the ability of the proposed
biosimilar trastuzumab to increase affordability,
competition, and access for patients, and the companies' intention
to seek final approval from FDA. 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, India 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.