HERTFORDSHIRE, England and
PITTSBURGH and BENGALURU,
India, June
4, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that
the U.S. Food and Drug Administration (FDA) has approved Mylan's
Fulphila™ (pegfilgrastim-jmbd), a biosimilar to
Neulasta® (pegfilgrastim), co-developed with
Biocon. Fulphila has been approved to reduce the duration of
febrile neutropenia (fever or other signs of infection with a low
count of neutrophils, a type of white blood cells) in patients
treated with chemotherapy in certain types of cancer.
Fulphila is the first FDA-approved biosimilar to Neulasta and
the second biosimilar from Mylan and Biocon's joint portfolio
approved in the U.S. Mylan anticipates launching Fulphila in the
coming weeks, representing the first alternative, more affordable
treatment option to Neulasta for oncology patients. A suite of
patient services also will be available at launch to further
support patients and caregivers with treatment.
Mylan CEO Heather
Bresch commented: "I couldn't be prouder of this
approval for Fulphila, the first alternative option for
pegfilgrastim approved in the U.S., as it represents an important
milestone for patients and further demonstrates Mylan's continued
fight to expand access to medicine. FDA's approval of this product,
as well as the agency's continued focus on biosimilars, mark
crucial steps towards lowering treatment costs and providing
alternative options for patients. As a leading supplier of cancer
medicines in the U.S, Mylan is committed to offering affordable and
accessible solutions for patients with cancer at every step of
their journey. Enhancing access to treatment has always been our
top priority and what we'll continue to deliver to the healthcare
system in the U.S. and beyond."
Mylan President
Rajiv Malik added:
"Today's approval of Fulphila represents a meaningful step forward
in the affordability and accessibility of cancer care in the U.S.
It also is yet another confirmation of Mylan's deep scientific,
clinical, regulatory and intellectual property capabilities, which
are widely recognized in the industry and bolster Mylan's
reputation as a partner of choice in the global effort to
bring complex medicines to market. The approval of Fulphila, the
first biosimilar to Neulasta, joins other recent examples such as
the approval of Ogivri™, the first biosimilar to
Herceptin®, in the growing portfolio of complex
medicines that Mylan is making available for patients who need
them. We're pleased to reach this important milestone in
partnership with Biocon and proud of the progress of our
biosimilars program. We look forward to launching Fulphila and
continuing to increase access to more affordable treatments."
As a global leader in the development and manufacturing of
complex products, Mylan has a portfolio of 20 biosimilar and
insulin analog products – one of the industry's largest and most
diverse portfolios – and deep experience with more than 60
marketing authorizations for biosimilar products worldwide.
Mylan was the first company to receive FDA approval of
Ogivri1, a biosimilar to
Herceptin (trastuzumab), in late 2017 and has continued
to obtain regulatory approvals for biosimilar trastuzumab in nearly
30 additional countries around the world.
Biocon CEO & Joint Managing Director, Dr. Arun Chandavarkar, said: "It's a
moment of great pride to be the first to receive approval for a
biosimilar pegfilgrastim by the USFDA. This important
milestone comes soon after our achievement of being the first to
receive USFDA approval for biosimilar trastuzumab. It
represents a further endorsement of the Biocon-Mylan partnership's
ability to successfully develop complex molecules to exacting
quality and regulatory standards. This approval expands our
oncology portfolio for the benefit of cancer patients and supports
our mission to improve access to high quality, affordable
biopharmaceuticals globally."
The approval for Fulphila was based on a comprehensive package
of analytical, nonclinical and clinical data, which confirmed that
the product is highly similar to Neulasta. The data demonstrated
that there were no clinically meaningful differences between the
biosimilar product and Neulasta in terms of safety, purity and
potency.
Neulasta had U.S. sales of $4.2
billion for the 12 months ending March 31, 2018, according to IQVIA.
Fulphila is not indicated for the mobilization of peripheral
blood progenitor cells for hematopoietic stem cell transplantation.
Do not administer Fulphila to patients with a history of serious
allergic reactions to pegfilgrastim or filgrastim. Splenic rupture
and sickle cell crisis, including fatal cases, can occur following
the administration of Fulphila. Discontinue Fulphila in
patients with Acute Respiratory Distress Syndrome and consider dose
reduction or interruption in patients with glomerulonephritis. The
most common adverse reactions are bone pain and pain in
extremity.
1 Ogivri is approved for the treatment of
HER2-overexpressing breast cancer and metastatic stomach cancer
(gastric or gastroesophageal junction adenocarcinoma). It 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
Neulasta, represent a large and increasing portion of the overall
prescription drug market. They are important in the treatment of
many chronic and acute diseases, including cancer. However, these
drugs can cost far more than traditional prescription drugs, and
their cost can prohibit access. According to a survey from the
American Society for Clinical Oncology, more than half (56%) of
respondents said they were very or somewhat concerned they could
afford treatment. 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 to Neulasta 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
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: the expected launch and marketing of
Fulphila; Fulphila being expected to be the first biosimilar
pegfilgrastim available in the U.S. to help patients with
nonmyeloid cancers reduce the risk of infection following
myelosuppressive chemotherapy; that Fulphila is the second
FDA-approved biosimilar through the Mylan-Biocon collaboration,
demonstrating the companies' leadership and commitment to expanding
patient access to critical biologic medicine; Mylan anticipating
launching Fulphila in the coming weeks, representing the first
alternative, more affordable treatment option to Neulasta for
oncology patients; a suite of patient services also being available
at launch to further support patients and caregivers with
treatment; FDA's approval of this product, as well as the agency's
continued focus on biosimilars, marks a crucial step towards
lowering treatment costs and providing alternative options for
patients; and that we look forward to launching Fulphila and
continuing to increase access to more affordable treatments. 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: that the partnership is subject to approval by the
Israeli Innovation Authority; 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.