HERTFORDSHIRE, England,
PITTSBURGH and BENGALURU,
India, Dec.
1, 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 approved Mylan's Ogivri™
(trastuzumab-dkst), a biosimilar to
Herceptin®
(trastuzumab), co-developed with Biocon. Ogivri has been
approved for all indications included in the label of the reference
product, Herceptin, including for the treatment of
HER2-overexpressing breast cancer and metastatic stomach cancer
(gastric or gastroesophageal junction adenocarcinoma).
(1)
Ogivri is the first FDA-approved biosimilar to Herceptin
and the first biosimilar from Mylan and Biocon's joint portfolio
approved in the U.S. Mylan anticipates
potentially being the first company to offer
a biosimilar to Herceptin, as a result of Mylan's ability to
secure global licenses for its trastuzumab
product from Genentech and Roche earlier this
year. This milestone secured a clear
pathway to commercialize Mylan's biosimilar to
Herceptin in various markets
globally.
Mylan is a global leader in the development and
manufacturing of complex products, including biosimilar medicines,
with a portfolio of 16 biosimilar and insulin analog products – one
of the industry's largest and most diverse portfolios.
Mylan CEO Heather Bresch
commented: "The approval of Ogivri
represents a monumental achievement for Mylan to increase patient
access to biosimilars and deliver significant savings to the U.S.
healthcare system. It will allow us to bring this important
biosimilar – the first of its kind – to market in the U.S.,
expanding cancer-patient access to more affordable treatment. As
one of the nation's leading suppliers of cancer medicines, Mylan is
excited to add to our portfolio a product representing a
new generation of targeted therapies that have radically changed
the way the disease is treated. Ogivri is one of many biosimilars
in our robust pipeline that we look forward to introducing in the
coming years as part of our ongoing commitment to increasing access
to important medicines for patients."
Mylan
President Rajiv Malik
added: "We are proud to receive FDA
approval of Ogivri, a biosimilar to Herceptin, as this further
underscores the strength of our science team and our ability to
execute science programs for hard-to-make and complex products like
biosimilars. Bringing such complex products to the market not only
requires sound and robust science and a talented research and
development team, but also the ability to manage legal and
regulatory complexities and invest significantly in manufacturing
capabilities.
"This latest approval, among our other many
accomplishments around the globe, not only continues to highlight
Mylan's ability to differentiate itself from its peers, but also
underscores why we have become a preferred partner of
choice."
Kiran Mazumdar-Shaw, CMD
Biocon, said: "The U.S. FDA's approval for
our biosimilar trastuzumab is indeed a crowning moment that puts us
in an exclusive league of global biosimilar players. It strengthens
our resolve to focus on developing affordable biologics that can
make cancer care both more effective and more equitable around the
world. It is an important milestone in our journey of developing
advanced therapies that have the potential to benefit billions of
patients.
"Biocon and Mylan have a shared commitment to enhance
access to cutting-edge bio-therapeutics and this approval will
enable us to provide an affordable alternative for cancer care that
will address the unmet needs of patients in the U.S."
Dr. Arun Chandavarkar,
CEO & Joint MD, Biocon, added: "This approval
represents a landmark achievement for the Biocon-Mylan
collaboration and is an important endorsement of our development
and manufacturing capabilities in the area of monoclonal
antibodies. I sincerely acknowledge the contribution of every
member of our teams who made this happen. This is the first
biosimilar trastuzumab to be approved by the U.S. FDA and opens the
door to a high quality, more affordable option for the treatment of
eligible cancer patients in the U.S."
FDA approval was based on robust data from structural and
functional characterization using multiple orthogonal techniques,
nonclinical studies and pharmacokinetic evaluation in healthy
subjects and patients and a safety, efficacy and immunogenicity
study in relevant patient populations, which compared Ogivri to
Herceptin. The data demonstrated that Ogivri is highly similar to
Herceptin and no clinically meaningful differences exist between
the biosimilar product and Herceptin in terms of safety, purity and
potency. The FDA's decision follows the unanimous vote by the FDA
Oncologic Drugs Advisory Committee (ODAC) in July 2017 recommending approval of Mylan's
biosimilar to Herceptin.
Mylan and Biocon's biosimilar for Herceptin also is under
review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is
already approved in 19 countries around the world, including
India, thus providing increased
access to this more affordable biologic for cancer
patients.
In the U.S., an estimated 250,000 new cases of female
breast cancer and 28,000 new cases of stomach cancer are expected
to be diagnosed in 2017 alone. Approximately 20% to 25% of primary
breast cancers are HER2-positive. Herceptin had U.S. sales of more
than $2 billion for the 12 months
ending Sept. 30, 2017, according to
IQVIA.
Mylan is dedicated to supporting patients at every stage
of cancer care with approximately 40 oncology supportive care,
therapeutic and diagnostic products in the U.S.
(1) Ogivri may cause cardiomyopathy,
infusion reactions, embryo-fetal toxicity and pulmonary
toxicity.
- Cardiomyopathy: Ogivri can result in subclinical and
clinical cardiac failure manifesting as CHF, and decreased LVEF,
with greatest risk when administered concurrently with
anthracyclines. Evaluate cardiac function prior to and during
treatment. Discontinue Herceptin for cardiomyopathy.
- Infusion Reactions, Pulmonary Toxicity: Discontinue
Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or
acute respiratory distress syndrome.
- Embryo-Fetal Toxicity: Exposure to Herceptin during
pregnancy can result in oligohydramnios, in some cases complicated
by pulmonary hypoplasia and neonatal death. Advise patients of
these risks and the need for effective contraception.
Bringing Access to Biologics
Biologic drugs, like Herceptin, represent a large and
increasing portion of the overall prescription drug market. They
are important in the fight against many chronic and
life-threatening diseases, including cancer. However, these drugs
can cost far more than traditional prescription drugs, and their
cost can prohibit access. For example,
more than 20% of cancer patients skipped recommended
treatments due to high out-of-pocket expenses. Biologics accounted
for 70% of drug spending growth between 2010 and 2015.
Biosimilar medicines are deemed by FDA to be highly
similar to an already-approved biologic product. They fill an
urgent and unmet need for more affordable alternatives to biologic
therapies, increasing access and providing savings for patients and
the overall healthcare system. It is projected that biosimilars
will generate a savings of $54
billion in direct spending on biologic drugs in the U.S.
between 2017 and 2026.
About the Biocon and Mylan
Partnership
Mylan and Biocon are
exclusive partners on a broad portfolio of biosimilar and insulin
products. Our biosimilar for Herceptin is one of the six biologic
products co-developed by Mylan and Biocon for the global
marketplace. Mylan has exclusive commercialization rights for the
product 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 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 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. We routinely post information that may be
important to investors on our website at
investor.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, 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), KRABEVA ® ( Bevacizumab) 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
Mylan anticipating potentially being the first company to
offer a biosimilar to Herceptin, as a result of Mylan's ability to
secure global licenses for its trastuzumab product from Genentech
and Roche earlier this year; this milestone securing a clear
pathway to commercialize Mylan's biosimilar to Herceptin in various
markets globally; the approval increasing patient access to
biosimilars and delivering significant savings to the U.S.
healthcare system; the approval allowing Mylan to bring this
important biosimilar – the first of its kind – to market in the
U.S., expanding cancer-patient access to more affordable treatment;
Ogivri being one of many biosimilars in Mylan's robust
pipeline that we look looking forward to introducing in the coming
years as part of our ongoing commitment to increasing access to
important medicines for patients; and the
approval further underscoring
Mylan's strength and ability to execute the science programs for
hard-to-make and complex products like
biosimilars.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
This Press Release may include forward-looking information
to enable investors to comprehend our prospects and take informed
investment decisions. The statements - written and oral - that we
periodically make contain forward looking statements that set out
anticipated results based on the management's plans and
assumptions. We have tried wherever possible to identify such
statements by using words such as 'anticipates', 'estimates',
'expects', 'projects', 'intends', 'plans', 'believes' and words of
similar substance in connection with any discussion of future
performance. The market data & rankings used, are based on
several published reports and internal company assessment. We
cannot guarantee that these forward- looking statements will be
realized, although we believe we have been prudent in our
assumptions. The achievement of results is subject to risks,
uncertainties and even inaccurate assumptions. Should known or
unknown risks or uncertainties materialize, or should underlying
assumptions prove inaccurate, actual results could vary materially
from those anticipated, estimated or projected. Readers should bear
this in mind. We undertake no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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SOURCE Mylan N.V.