HERTFORDSHIRE, England,
PITTSBURGH and BENGALURU,
India, Nov.
30, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL)
and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced
that the European Medicines Agency (EMA) has accepted for review
Mylan's Marketing Authorization Applications (MAA) for proposed
biosimilar trastuzumab and proposed biosimilar pegfilgrastim.
Trastuzumab is used to treat certain HER2-positive breast and
gastric cancers. Pegfilgrastim 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.
EMA acceptance of the submissions follows an earlier withdrawal
of both applications in response to an audit conducted by the
European inspecting authority of Biocon's drug product facility.
Biocon has completed the Corrective and Preventive Actions (CAPAs)
outlined as a result of the audit observations. The CAPAs will be
confirmed during reinspection, which will be completed as part of
the regulatory review process.
Good Manufacturing Practice (GMP) compliance certificates for
Biocon's two drug substance manufacturing facilities in
Bangalore have been issued
previously. Approval of these sites is key in the development and
approval process as drug substance manufacture is core to the
production of the actual biologic product in GMP compliance.
Mylan President Rajiv
Malik commented: "We are extremely pleased with the
acceptance of our MAAs. Having gone through initial reviews of the
applications and after completing the CAPAs from the EMA audit, we
are even more confident with the strength of our MAAs.
Additionally, the Voluntary Action Indicated (VAI) designation we
received from FDA gives us further confidence in the readiness of
the manufacturing site. We now look forward to moving ahead with
the rest of the regulatory review process in Europe and to bringing these important
treatment options to cancer patients.
"These developments also demonstrate Mylan's commitment to our
partnership with Biocon, the strength of the collaboration's
scientific and manufacturing capabilities, and our relentless
approach to increasing access to and affordability of important
treatment options in Europe and
around the world through the introduction of biosimilars."
Dr Arun Chandavarkar, CEO
& Joint Managing Director, Biocon said: "EMA's acceptance
for review of the Marketing Authorization Applications (MAAs)
for our proposed biosimilars of trastuzumab and pegfilgrastim is
indeed a welcome development. These applications were resubmitted
upon completion of the Corrective and Preventive Actions (CAPAs),
including the modifications of our aseptic drug product facility.
We expect these CAPAs to be verified during inspection as part of
the review process. We continue to work closely with our partner
Mylan in engaging with EMA to provide these high quality,
affordable therapy options for cancer patients in Europe."
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),
Evertor® (Everolimus) 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
CAPAs being confirmed during reinspection, which will be
completed as part of the regulatory review process; Mylan
being even more confident with the strength of our MAAs; the VAI
designation we received from FDA giving us further confidence in
the readiness of the manufacturing sites; looking forward to moving
ahead with the rest of the regulatory review process in
Europe and to bringing these
important treatment options to cancer patients; and that these
developments demonstrate Mylan's commitment to our partnership with
Biocon, the strength of the collaboration's scientific and
manufacturing capabilities, and our relentless approach to
increasing access to and affordability of important treatment
options in Europe and around the
world through the introduction of 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 statements of future
expectations and other forward-looking statements based on
management´s current expectations and beliefs concerning future
developments and their potential effects upon Biocon and its
subsidiaries/ associates. These forward-looking statements involve
known or unknown risks and uncertainties that could cause actual
results, performance or events to differ materially from those
expressed or implied in such statements. Important factors that
could cause actual results to differ materially from our
expectations include, amongst other: general economic and business
conditions in India and overseas,
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 and global
biotechnology and pharmaceuticals industries, changes in political
conditions in India and changes in
the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or
any of our subsidiaries/associates assume any obligation to update
any particular forward-looking statement contained in this
release.
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SOURCE Mylan N.V.