HERTFORDSHIRE, England,
PITTSBURGH and BENGALURU,
India, Oct.
19, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that
the European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) has issued a positive opinion recommending
approval of Ogivri®, a biosimilar to Roche's
Herceptin® (trastuzumab).
The positive CHMP opinion is based on data submitted as part of
the Marketing Authorization Application which included similarity
assessment in analytical testing, preclinical and clinical studies.
Results demonstrated no clinically meaningful differences in
quality, potency and safety; therefore, establishing biosimilarity
to the reference product, Herceptin. In addition, the Phase III
clinical study (Heritage) demonstrated no clinically meaningful
differences in terms of safety, efficacy and immunogenicity when
compared to Herceptin in metastatic breast cancer patients, further
reinforcing the highly similar nature of
Ogivri.
The CHMP positive opinion will now be considered by the European
Commission. The decision on approval is expected by the end of
2018.
Ogivri is indicated for treatment of patients with HER2 positive
early breast cancer (EBC), metastatic breast cancer (MBC) and
metastatic gastric cancer (MGC). Under supervision of the relevant
healthcare professional it can be prescribed as either monotherapy
or in combination with other medicines dependent on the relevant
diagnosis.
Mylan President
Rajiv Malik commented:
"Obtaining positive CHMP opinion for Ogivri is another significant
achievement in Mylan's continued efforts to bring more affordable
medicines to the market. The strong science and technology program
behind this product has been instrumental in achieving this
milestone and moving us one step closer to providing patients with
this alternative option. Mylan has a comprehensive and diverse
biosimilars portfolio, and we are dedicated to bringing these
complex medicines to market around the world."
Dr. Arun Chandavarkar, CEO and
Joint Managing Director, Biocon said: "CHMP's positive opinion
on Biocon and Mylan's biosimilar trastuzumab is yet another
endorsement of our ability to develop and manufacture complex
biosimilars for the benefit of patients globally. This is the third
molecule from our collaboration portfolio to receive positive
opinion from the European CHMP. We shall continue to execute
on our biosimilars strategy of expanding affordable access to high
quality products targeting critical illnesses like cancer."
Herceptin had brand sales of approximately $1.9 billion in Europe for the 12 months ending July 31, 2018, according to IQVIA.
Ogivri was approved by the U.S. Food and Drug Administration
(FDA) in 2017 and is the first FDA-approved biosimilar for
Herceptin in the U.S. Additional regulatory approvals have been
secured in 35 countries around the world.
About Trastuzumab
Biological agents, including
monoclonal antibodies, have increased the treatment options and
improved outcomes for a number of cancers. Trastuzumab combined
with chemotherapy has improved response, progression-free survival
(PFS) and overall survival for ERBB2 (formerly human epidermal
growth factor receptor 2 [HER2] or HER2/neu) –positive metastatic
breast cancer and improved survival in early-stage ERBB2 positive
breast cancer and metastatic ERBB2-positive gastric cancer compared
with chemotherapy alone.
About the Biocon and Mylan Partnership
Mylan and Biocon are exclusive partners on a broad portfolio of
biosimilar and insulin products. Ogivri is one of 11 biologic and
insulin 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 a
fully-integrated, innovation-led global biopharmaceutical company
committed to enhance affordable access to complex therapies for
chronic conditions like diabetes, cancer and autoimmune. It has
developed and taken differentiated Small Molecules, Novel Biologics
and a range of Biosimilars (Monoclonal Antibodies, rh Insulin and
Insulin Glargine) from 'Lab to Market' in India, key emerging and developed markets. It
has a large portfolio of biosimilars under clinical development
with three of these approved in developed markets of US, EU,
Japan and Australia. Its Novel pipeline includes
promising assets like Insulin Tregopil, anti-CD6 antibody and a
fusion protein for immuno-oncology. Some of its key brands are
INSUGEN® (rh-insulin), Basalog One® (prefilled Glargine pen),
CANMAb™ (Trastuzumab), KRABEVA® (Bevacizumab), BIOMAb-EGFR®
(Nimotuzumab) and ALZUMAb™ (Itolizumab). Follow-us on
Twitter: @bioconlimited and visit www.biocon.com for more
information.
Forward-Looking Statements: Mylan
This press
release includes statements that constitute "forward-looking
statements", including with regard to: the outcome of clinical
studies; and that the decision on approval is expected by the end
of 2018. 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: success of clinical trials and our or our partners'
ability to execute on new product opportunities; any regulatory,
legal or other impediments to our or our partners' ability to bring
products to market; other risks inherent in product development;
the scope, timing, and outcome of any ongoing legal proceedings,
including government investigations, and the impact of any such
proceedings on our or our partners' businesses; actions and
decisions of healthcare and pharmaceutical regulators, and changes
in healthcare and pharmaceutical laws and regulations, in
the United States and abroad; the
impact of competition; strategies by competitors or other third
parties to delay or prevent product introductions; the effect of
any changes in our or our partners' customer and supplier
relationships and customer purchasing patterns; any other changes
in third-party relationships; changes in the economic and financial
conditions of the businesses of Mylan or its partners;
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.