BENGALURU, India
and HERTFORDSHIRE, England
and PITTSBURGH and SAO PAULO, Dec. 29, 2017 /PRNewswire/ --
Biosimilar Trastuzumab, co-developed by Biocon Ltd. (BSE code:
532523, NSE: BIOCON) and Mylan N.V. (NASDAQ, TASE: MYL), has been
approved by ANVISA, the Brazilian regulatory agency, through their
partner Libbs Farmaceutica (Libbs), a leading Brazilian
pharmaceutical company.
Co-developed by Biocon and Mylan, this is the first biosimilar
Trastuzumab to be approved in Brazil and is indicated for the treatment of
overexpressing HER2-positive metastatic breast cancer,
HER2-positive early stage breast cancer and HER2-positive advanced
gastric cancer. Libbs will commercialize the product in
Brazil under the brand name
Zedora, which will provide affordable access to a cutting-edge
biologics therapy for patients in Brazil.
Dr. Arun Chandavarkar, CEO and Joint Managing
Director, Biocon, said: "This marks the first
approval for a biosimilar Trastuzumab by Brazil's ANVISA and demonstrates our
commitment to provide access to high-quality and affordable
biologics to patients across the globe. Cancer patients in
India and some emerging markets
have benefited with our Trastuzumab and the approval in
Brazil will enable affordable
access to this critical biologic therapy for the treatment of
HER2-positive breast and gastric cancers in the country. We
are committed to make global impact with our affordable antibodies
against cancer."
Mylan CEO Heather
Bresch commented: "The number of women
diagnosed with breast cancer in Brazil is increasing. Sadly, many of the women
with HER2-positive metastatic breast cancer in Brazil do not have access to Trastuzumab
through the country's public health system. The approval of Zedora,
Brazil's first Trastuzumab
biosimilar, is an important step in our efforts to increase access
to this critical product for patients with certain breast and
gastric cancers and reduce the overall financial burden for health
systems around the world."
Alcebíades de Mendonça Athayde Júnior, Libbs CEO, said:
"The approval of Zedora will allow us to bring this
first-of-its-kind biosimilar Trastuzumab to breast and gastric
cancer patients in Brazil.
Biosimilar Trastuzumab, co-developed by Biocon and Mylan, can help
expand cancerpatient access to more affordable treatment and
contribute to significant savings to Brazil's healthcare system. Zedora will
strengthen our current product portfolio as a new generation
targeted therapy that can benefit cancer patients
immensely."
Biocon and Mylan are responsible for the development of
biosimilar Trastuzumab. While currently the trastuzumab will be
manufactured by Biocon and supplied to Libbs for commercialization
in Brazil; over a period of time
the technology will be transferred to Libbs and the public partner
Butantan through a Productive Development Partnership (PDP). Libbs
have already built the biotechnological site to manufacture Zedora
for the Brazilian market.
This is a significant approval as it sets the stage for the
entry of our biosimilar Trastuzumab into Brazil, which is among the top three emerging
markets globally for Trastuzumab. The pharmaceutical market in
Brazil is predicted to grow to
US$30 billion in 2021 from
US$26 billion in 2016.
(Source:GlobalData)
Breast cancer is the leading cause of cancer death in women in
Brazil, where new cases are
estimated to be over 57,000 annually, with an estimated incidence
of 56 cases per 100,000 women. It is the second-most common type of
cancer that affects women in Brazil, after non-melanoma skin cancer*.
Trastuzumab is now included on the WHO list of essential
medicines.
Earlier this month, Biocon and Mylan marked a major milestone
with the U.S. Food and Drug Administration approval of
their biosimilar Trastuzumab. Biocon and Mylan's biosimilar
Trastuzumab is also under review by regulatory authorities in
Australia, Canada, Europe and several additional markets. It is
already approved in several other countries around the world,
including India, where it is
providing increased access to this more affordable biologic for
cancer patients.
*Source: Instituto Nacional de Câncer José Alencar Gomes Da Silva. Estimativa 2014:
incidência de câncer no Brasil. Rio de
Janeiro, 2014.
About Biocon and Mylan Partnership
Mylan and
Biocon are exclusive partners on a broad portfolio of biosimilar
and insulin products. Our 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
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 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.
www.biocon.com , follow-us on Twitter: @bioconlimited
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 Libbs
Libbs is a 100% Brazilian pharmaceutical
company which has been in the market for 59 years and employs
around 2500 people. Currently, it is on the 8th position in
the ranking of pharmaceutical companies in the Brazilian national
retail market. The company invests 10% of its revenue in R&D
and innovation. It now has around 90 brands in the market in 200
different presentations distributed across several specialties,
including gynecology, central nervous system, cardiology, oncology
and dermatology. Libbs' biotechnology unit, called Biotec, was
launched in 2016 and is responsible for the production of
monoclonal antibodies. With a total production capacity of 400kg of
biopharmaceutical products per year, Biotec applies the single-use
system, a technology based on bioreactors with disposable bags. For
more information, please visit http://www.libbs.com.br
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.
Forward-Looking Statements: Mylan
This press
release includes statements that constitute "forward-looking
statements," including with regard to: providing affordable
access to cutting-edge biologics therapy for patients in
Brazil who are otherwise not able
to afford expensive originator products; the approval of Zedora,
Brazil's first trastuzumab
biosimilar, being an important step in our efforts to increase
access to this critical product for patients with certain breast
and gastric cancers and reduce the overall financial burden for
health systems around the world; and the pharmaceutical market in
Brazil being predicted to grow to
U.S. $30 billion in 2021 from U.S.
$26 billion in 2016. 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.
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SOURCE Mylan N.V.