HERTFORDSHIRE, England
and PITTSBURGH and BENGALURU, India, Aug. 31,
2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and
Biocon Biologics India Ltd., a subsidiary of Biocon Ltd. (BSE code:
532523, NSE: BIOCON), today announced the U.S. launch of Semglee™
(insulin glargine injection) in vial and pre-filled pen
presentations, approved to help control high blood sugar in adult
and pediatric patients with type 1 diabetes and adults with type 2
diabetes. It is not recommended for the treatment of diabetic
ketoacidosis. Semglee, which received final approval from the U.S.
Food and Drug Administration (FDA), has an identical amino acid
sequence to Sanofi's Lantus® and is approved for the same
indications.
Dr. Thomas Blevins, M.D., lead
investigator for the INSTRIDE clinical trials, said: "The
availability of Semglee provides another quality treatment option
for patients living with diabetes in the U.S. We rigorously
compared Semglee (insulin glargine injection) to the reference
insulin glargine in participants with Type 1 and 2 diabetes and
found that Semglee yielded similar (non-inferior) glycemic results
in both groups. The safety, including immunogenicity, was similar
too. As a result, this insulin was approved by the FDA for the same
indications as its reference product Lantus, thus expanding access
for millions of people within this important patient
community."
To encourage broad patient access to this important medicine,
Mylan is offering Semglee at a wholesale acquisition cost
(WAC)1 of $147.98 per
package of five (5) 3ml pens and $98.65 per 10ml vial, representing the lowest WAC
for any long-acting insulin glargine on the market. The list price
of Semglee pen is equivalent to the Lantus launch price in 2007,
and the Semglee vial is listed at Lantus's 2010 pricing. Eligible
patients may also qualify for patient assistance and/or a co-pay
card, similar to other medications in this class. Additionally,
Mylan has submitted to FDA all necessary documentation to request
approval of Semglee as a biosimilar to Lantus under the 351(k)
pathway and remains confident in seeking an interchangeability
designation.
Mylan CEO Heather
Bresch said: "We are proud to be the first
company, following the reference product, to receive FDA approval
on and launch both the vial and pen presentations of an insulin
glargine treatment with an identical amino acid sequence to
Sanofi's Lantus®. Even more importantly, we are proud to make
Semglee available to the more than 30 million Americans living with
diabetes in the U.S.2, providing more treatment options
and increasing access. While providing our product at the most
competitive list price on the market is an important step toward
ensuring that those who need insulin are able to access and afford
it, we also know that there is still work to be done to ensure this
access and affordability reaches patients at the pharmacy counter.
We remain committed to work across the healthcare system to improve
outcomes for all."
Mylan President
Rajiv
Malik said: "Bringing to market both
the vial and pen presentations of Semglee, the first for any
company following the reference product, required years of
investment and commitment, and represents another important example
of the power of the unique platform we've built along with our
partner Biocon Biologics in terms of our research and development,
regulatory, legal and commercial expertise. Today's launch also
furthers our continued efforts to serve patients through the
availability of a full portfolio of short- and long-acting
insulins, which also includes our insulin aspart that we expect to
launch next year. Our near-term strategy to ensure the availability
of Semglee will require a strategic and targeted phased launch
approach. Over the long term, we expect this addition to our
portfolio to play an increasingly important role within our global
biosimilars and insulin analog franchise as well as our efforts to
advance access to complex medicines."
Kiran Mazumdar-Shaw,
Executive Chairperson, Biocon said: "The
commercialization of our insulin glargine in the U.S. represents
another milestone achievement for Biocon in making insulin-based
therapy increasingly accessible for people with diabetes globally.
We are confident that along with our long-standing partner Mylan,
we will be able to address the needs of millions of patients living
with diabetes in the U.S. Leveraging our science and global
scale manufacturing expertise, we have been
expanding affordable access to biosimilar insulins to patients
in Japan, Australia, Europe, India
and key emerging markets. The U.S. launch of Semglee takes us
closer to realizing our aspiration of reaching 'one in five'
insulin dependent people with diabetes worldwide."
Dr. Christiane Hamacher,
CEO, Biocon Biologics said: "It is indeed a
proud moment for Biocon Biologics to make Semglee (insulin glargine
injection) available to patients in the U.S. Our unwavering focus
on developing and manufacturing global quality insulins enables us
to address the growing needs of diabetes patients and the
healthcare systems. We stay committed to expand affordable access
to life-saving global quality biosimilars and insulin analogs and
generating savings for the U.S. healthcare system. We believe the
U.S. market represents a great opportunity for us and expect
Semglee to contribute significantly to our goal of impacting 5
million patients' lives and achieving $1
billion revenue by end of FY22."
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
profile and immunogenicity of Semglee as compared to Lantus in
patients with type 1 and type 2 diabetes.
Today's launch follows favorable judgments on all remaining
patent claims asserted by Sanofi against Mylan's insulin glargine
products. Although Sanofi may seek certain appeals of those
judgments, Mylan is confident they will not affect
commercialization.
Sanofi's total IQVIA sales for the 12 months ending June 30, 2020 were approximately $1.64 billion for Lantus 100 Units/mL Vial and
approximately $4.36 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 medical supervision with
increased frequency of 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. Increase frequency of glucose monitoring with
changes to: insulin dosage, coadministered glucose lowering
medications, meal pattern, physical activity; and in patients with
renal or hepatic impairment and hypoglycemia unawareness. 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 injection. 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 and treat if indicated. Fluid retention and heart
failure have been reported with concomitant use of
thiazolidinediones (TZD). Observe for signs and symptoms of heart
failure; consider dosage reduction or discontinuation of TZD if
heart failure occurs.
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 Biologics India Limited:
Biocon Biologics
India Limited (Biocon Biologics), a subsidiary of Biocon Ltd, is
uniquely positioned as a fully integrated 'pure play' biosimilars
organization in the world. Building on the four pillars of
Patients, People, Partners and Business, Biocon Biologics is
committed to transforming healthcare and transforming lives. Biocon
Biologics is leveraging cutting-edge science, innovative tech
platforms and advanced research & development capabilities to
lower treatment costs while improving healthcare outcomes. It has a
platform of 28 biosimilar molecules across diabetes, oncology,
immunology, dermatology, ophthalmology, neurology, rheumatology and
inflammatory diseases. Five molecules from Biocon Biologics'
portfolio have been taken from lab to market, of which three have
been commercialized in developed markets like EU, Australia, United
States, Canada and
Japan. It aspires to benefit 5
million patient lives with its biosimilars and attain a revenue
milestone of USD 1 billion in
FY22. Follow-us on Twitter: @BioconBiologics
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
Forward-Looking Statements: Mylan
This press release
includes statements that constitute "forward-looking statements,"
including with regard to the launch of Semglee; that Semglee will
be available in vial and pen presentations at a 65% discounted list
price, the lowest available for a long-acting insulin glargine on
the market; that to encourage broad patient access to this
important medicine, Mylan is offering Semglee at a wholesale
acquisition cost (WAC) of $147.98 per package of five (5) 3ml pens and
$98.65 per 10ml vial, representing
the lowest WAC for any long-acting insulin glargine on the market;
that eligible patients may also qualify for patient assistance
and/or a co-pay card, similar to other medications in this class;
that additionally, Mylan has submitted to FDA all necessary
documentation to request approval of Semglee as a biosimilar to
Lantus under the 351(k) pathway and to seek an interchangeability
designation; while providing our product at the most competitive
list price on the market is an important step toward ensuring that
those who need insulin are able to access and afford it, we also
know that there is still work to be done to ensure this access and
affordability reaches patients at the pharmacy counter; bringing to
market both the vial and pen presentations of Semglee, the first
for any company following the reference product, required years of
investment and commitment, and represents another important example
of the power of the unique platform we've built along with our
partner Biocon Biologics in terms of our research and development,
regulatory, legal and commercial expertise; today's launch also
furthers our continued efforts to serve patients through the
availability of a full portfolio of short- and long-acting
insulins, which also includes our insulin aspart that we expect to
launch next year; our near-term strategy to ensure the availability
of Semglee will require a strategic and targeted phased launch
approach; over the long term, we expect this addition to our
portfolio to play an increasingly important role within our global
biosimilars and insulin analog franchise as well as our efforts to
advance access to complex medicines; today's launch follows
favorable judgments on all remaining patent claims asserted by
Sanofi against Mylan's insulin glargine products; and that although
Sanofi may seek certain appeals of those judgments, Mylan is
confident they will not affect commercialization. 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.
1 WAC does not necessarily reflect actual cost
to healthcare system or patients.
2 Centers 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.