HERTFORDSHIRE, England
and PITTSBURGH and BENGALURU, India, June 11,
2020 /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 the New
Drug Application (NDA) for Semglee™ (insulin glargine injection),
in vial and pre-filled pen presentations, to control high blood
sugar in adults with type 2 diabetes and adult and pediatric
patients with type 1 diabetes. Semglee has an identical amino acid
sequence to Sanofi's Lantus® and is approved for the
same indications.
Semglee, co-developed by Mylan and Biocon Biologics, was
approved as a drug product under the 505(b)(2) NDA pathway and is
now deemed a biologic under section 351(a) in accordance with the
Biologics Price Competition and Innovation Act in line with other
insulin products.
Mylan CEO Heather
Bresch said: "This approval is an important milestone,
first and foremost for the millions of patients living with
diabetes in the U.S. as we seek to expand their access to insulin
through more affordable treatment options. It's also another
milestone for Mylan as we continue to leverage our scientific,
commercial, manufacturing and regulatory expertise to benefit
patients, and as we enhance our portfolio with increasingly complex
and higher value-chain products, like insulin. Leveraging these
capabilities, whether through our internal teams or through strong
partnerships like the one we've built with Biocon, strengthens our
ability to deliver innovative solutions to patients in the U.S. and
around the world."
Mylan President Rajiv Malik added: "Today's milestone makes
Mylan the first company to have approvals on both the vial and pen
presentations of insulin glargine treatment options to
Lantus® and further reaffirms our proven scientific
track record in gaining approval for complex products like
Glatiramer Acetate, Yupelri®, biosimilars to
Neulasta® and Herceptin®, as well as a
drug-device combination product like Wixela®
Inhub®. I would like to recognize the extraordinary work
and leadership of both Mylan and Biocon's scientific and regulatory
teams for this achievement. As a leading provider of oral diabetes
medicine in the U.S., this approval expands our offerings to those
living with the disease while further demonstrating the power of
the unique platform we've built in terms of scientific excellence,
strong partnerships and the ability to leverage our regulatory and
commercial expertise around the world to bring higher value-chain
products to market. Semglee represents another component to our
global biosimilars franchise approach in advancing access to
complex medicines."
Malik continued, "Additionally, we believe that the strong
comprehensive analytical and clinical program supporting the
approval of Semglee will be central to our continued work to
achieve interchangeable product status, with the potential to
further reduce the cost burden for patients. We look forward to
making this product available to patients in the U.S. as soon as
possible."
Kiran Mazumdar Shaw, Chairperson,
Biocon, said: "The approval of our insulin glargine by the
U.S. FDA marks the culmination of a long journey. As an
organisation committed to making insulin-based therapy increasingly
accessible for people with diabetes globally, I am glad this
approval will enable us to serve the needs of patients in the U.S.
The approval is also an endorsement of our science, scale and
expertise to develop high quality, more affordable insulins and
shift the access paradigm in favour of patients, taking us closer
to realizing our aspiration of reaching 'one in five' insulin
dependent people with diabetes worldwide."
Dr Christiane Hamacher, CEO &
Managing Director, Biocon Biologics said, "We are extremely excited
with the opportunity to offer Semglee, co-developed with Mylan and
manufactured by Biocon Biologics, to the U.S. market, where
millions of patients need more affordable insulin analogs to
control their diabetes. Our combined scientific expertise and
global scale manufacturing capability complemented by a
comprehensive product presentation across vials and pens will
enable us to expand patient access to our insulin glargine through
our partner Mylan. We are making a significant difference to
patients in several countries across the world and
commercialization of Semglee in the U.S. will further expand
affordable access for patients with diabetes. Biocon Biologics is
committed to impact 5 million patient lives globally by FY 22."
She added: "The global INSTRIDE clinical studies have
demonstrated no difference in safety, efficacy and immunogenicity
of Semglee in comparison to the reference product, Lantus, in type
1 and type 2 diabetes. Our goal is to enable access to patients in
need of insulins, and we are working towards creating a patient
ecosystem that helps in lowering co-morbidities and achieving
overall cost savings for the healthcare systems."
The approval for Semglee was based on a comprehensive
analytical, preclinical and clinical program (including the
INSTRIDE studies) which confirmed the PK/PD, efficacy, safety and
immunogenicity of Semglee in comparison to Lantus in patients with
type 1 and type 2 diabetes.
Favorable judgments on all remaining patent claims asserted by
Sanofi against Mylan's insulin glargine products have been
obtained. Although Sanofi may seek certain appeals of those
judgments, Mylan is confident they will not affect
commercialization plans.
Sanofi's total IQVIA sales for the 12 months ending April 30, 2020 were approximately $1.68 billion for Lantus 100 Units/mL Vial and
approximately $4.33 billion for
Lantus SoloSTAR Pen.
Mylan and Biocon Biologic's insulin glargine has received
regulatory approval in more than 45 countries around the world and
is the third product approved by FDA through the Mylan-Biocon
Biologics collaboration.
About the INSTRIDE Studies
The INSTRIDE 1 and INSTRIDE
2 studies were randomized, confirmatory clinical trials designed to
evaluate the efficacy and safety of Mylan's proposed insulin
glargine, MYL-1501D, versus branded insulin glargine, Lantus.
INSTRIDE 1 was a 52-week noninferiority study in 558 T1DM patients,
while INSTRIDE 2 was a 24-week study in 560 T2DM (including
insulin-naïve) patients. In both studies, patients were randomized
to receive either once daily MYL-1501D or Lantus and the
primary endpoint was change from baseline in HbA1c after 24 weeks.
Secondary endpoints included glycemic endpoints like change from
baseline in fasting plasma glucose and insulin dose, as well as
safety endpoints like systemic reactions, device-related safety
issues and immunogenicity. The safety, efficacy and immunogenicity
data from these studies in T1DM and T2DM patients indicated that
there were no differences in the Semglee and Lantus arms.
Important Safety Information
Semglee is a long-acting
human insulin analog indicated to improve glycemic control in
adults and pediatric patients with Type 1 diabetes mellitus and in
adults with type 2 diabetes mellitus. It is not recommended for the
treatment of diabetic ketoacidosis. Do not use during episodes of
hypoglycemia or if hypersensitive to insulin glargine or it's
excipients. Patients should be instructed to never share the
prefilled pen even if the needle is changed. Changes to a patient's
insulin regimen should be done under close supervision with
increased blood glucose monitoring as hyper- or hypoglycemia may
occur. Hypoglycemia is the most common adverse reaction with
insulin, including Semglee and it may be life-threatening.
Patients and caregivers must be educated to recognize and manage
hypoglycemia. Medication errors can result from accidental
mix-ups among insulin products. Instruct patients to always check
the insulin label before administration. Severe, life-threatening
generalized allergy, including anaphylaxis can occur with insulin
products, including Semglee. If hypersensitivity reaction occurs,
discontinue Semglee and treat per standard of care and monitor
until symptoms and signs resolve. Monitor potassium levels
for hypokalemia. Fluid retention and heart failure have been
reported with concomitant use of thiazolidinediones and
Semglee.
About the Mylan and Biocon Biologics
Collaboration
Mylan and Biocon Biologics are exclusive
partners on a broad portfolio of biosimilars and insulin analogs.
Mylan has exclusive commercialization rights for insulin glargine
in the U.S., Canada, Australia, New
Zealand, the European Union and European Free Trade
Association countries. Biocon Biologics has exclusive rights for
Japan and a few emerging markets,
and co-exclusive commercialization rights with Mylan 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
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which approximately 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 approximately 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 Limited
Biocon Limited, publicly listed
in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013)
is an innovation-led global biopharmaceuticals company committed to
enhance affordable access to complex therapies for chronic
conditions like diabetes, cancer and autoimmune. It has developed
and commercialized novel biologics, biosimilars, and complex small
molecule APIs in India and several
key global markets as well as generic formulations in the US and
Europe. It also has a pipeline of
promising novel assets in immunotherapy under development.
www.biocon.com Follow-us on Twitter: @bioconlimited
Biocon Biologics is a subsidiary of Biocon Ltd. It is uniquely
positioned as a fully integrated 'pure play' biosimilars
organization in the world and aspires to transform patient lives
through innovative and inclusive healthcare solutions. The
Company's portfolio of biosimilar molecules comprises a rich
pipeline of approved and in-development biosimilars, which are an
outcome of its high end R&D and global scale manufacturing
expertise. The Company has commercialized three of its biosimilars
in the developed markets like EU, U.S., Japan and Australia. It is a leading global insulins
player with over 15 years of experience in addressing the needs of
patients with diabetes, having provided over 2 billion doses of
human insulin worldwide, thus far. Follow-us on Twitter:
@BioconBiologics
Forward-Looking Statements: Mylan
This press
release includes statements that constitute "forward-looking
statements," including with regard to the regulatory approval
commercialization of products; the potential outcome of litigation;
that Semglee is to be offered in vial and pen presentations; that
this is another milestone for Mylan as we continue to leverage our
scientific, commercial, manufacturing and regulatory expertise to
benefit patients, and as we enhance our portfolio with increasingly
complex and higher value-chain products, like insulin; that
leveraging these capabilities, whether through our internal teams
or through strong partnerships like the one we've built with
Biocon, strengthens our ability to deliver innovative solutions to
patients in the U.S. and around the world; that today's
milestone makes Mylan the first company to have approvals on both
the vial and pen presentations of insulin glargine treatment
options to Lantus® and further reaffirms our proven
scientific track record in gaining approval for complex products
like Glatiramer Acetate, Yupelri®, biosimilars to
Neulasta® and Herceptin®, as well as a
drug-device combination product like Wixela®
Inhub®; that as a leading provider of oral
diabetes medicine in the U.S., this approval expands our
offerings to those living with the disease while further
demonstrating the power of the unique platform we've built in terms
of scientific excellence, strong partnerships and the ability to
leverage our regulatory and commercial expertise around the world
to bring higher value-chain products to market; that Semglee
represents another component to our global biosimilars franchise
approach in advancing access to complex medicines; we believe that
the strong comprehensive analytical and clinical program supporting
the approval of Semglee will be central to our continued work to
achieve interchangeable product status, with the potential to
further reduce the cost burden for patients; we look forward to
making this product available to patients in the U.S. as soon as
possible; that favorable judgments on all remaining patent claims
asserted by Sanofi against Mylan's insulin glargine products have
been obtained; and although Sanofi may seek certain appeals of
those judgments, Mylan is confident they will not affect
commercialization plans. Because forward-looking statements
inherently involve risks and uncertainties, actual future results
may differ materially from those expressed or implied by such
statements. Factors that could cause or contribute to such
differences include, but are not limited to the potential
widespread and highly uncertain impact of public health outbreaks,
epidemics and pandemics, such as the COVID-19 pandemic; any changes
in, interruptions to, or difficulties with Mylan's or its partners'
ability to develop, manufacture, and commercialize products; 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; any regulatory, legal, or other
impediments to Mylan's or its partners' ability to bring products
to market; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United States
and abroad; Mylan's and its partners' ability to protect
intellectual property and preserve intellectual property rights;
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.
1Centers for Disease Control and Prevention. National
Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and
Prevention, US Department of Health and Human Services; 2020.
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SOURCE Mylan N.V.
