PITTSBURGH and BENGALURU,
India, July
28, 2021 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS)
and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today
announced that the U.S. Food and Drug Administration (FDA) has
approved Semglee® (insulin glargine-yfgn injection) as
the first interchangeable biosimilar product under the 351(k)
regulatory pathway.
Viatris CEO Michael Goettler
commented: "We are extremely proud to achieve the industry's first
approval of an interchangeable biosimilar product in the U.S.,
which will help broaden access to this important diabetes medicine
for patients, physicians, payers and providers. This is yet another
important milestone for our company that not only continues to
underscore the strength of our internal scientific capabilities,
but also supports our belief in the promising future of our company
as we continue to work to identify innovative ways to increase
access to complex treatments for patients."
Viatris President Rajiv Malik
added: "We are very pleased to have once again worked with the FDA
to achieve the very historic approval of the first interchangeable
biosimilar in the U.S. and are grateful to our partner, Biocon
Biologics, for their collaboration in achieving this milestone. Our
continued ability to break down barriers to access, bring forth
first-to-market products and blaze new trails is a testament to the
strength of our scientific, regulatory, operations and legal
expertise as well as our focus on patients."
The interchangeable Semglee product, which will allow
substitution of Semglee for the reference product, Lantus®, at the
pharmacy counter, will be introduced before the end of the year.
The company is eligible to have exclusivity for 12 months before
the FDA can approve another biosimilar interchangeable to Lantus.
Commercial preparations for launch are underway. Over the next few
months, Viatris will transition the current product to the 351(k)
interchangeable product.
Semglee is indicated to control high blood sugar in adults with
Type 2 diabetes and adults and pediatric patients with Type 1
diabetes. It is not recommended for the treatment of diabetic
ketoacidosis. Semglee has an identical amino acid sequence to
Lantus and is approved for the same indications.
Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said: "We are extremely
proud to be the first to obtain approval of an interchangeable
Biosimilar product in the U.S. It is a milestone achievement for
both Biocon Biologics and our partner Viatris. This will allow
pharmacy level substitution and thereby provide convenient and
affordable access to Semglee, a quality Biosimilar Insulin
Glargine."
Biocon Biologics Managing Director Arun
Chandavarkar said: "This interchangeability approval for
Semglee by the U.S. FDA, another first to our credit, is a
testament to our scientific excellence and robust quality
comparability data. This allows substitution at the pharmacy
counter, thus expanding patient access and sets the stage for
future approvals for our other insulin products."
Viatris and Biocon Biologic's insulin glargine has received
regulatory approval in more than 60 countries around the world and
was the third product approved by the FDA through the
Viatris-Biocon Biologics collaboration.
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
when there are 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 Viatris and Biocon Biologics
Collaboration
Viatris and Biocon Biologics have an exclusive
collaboration for the development, manufacturing and
commercialization of a broad portfolio of biosimilars and insulin
analogs. Viatris has exclusive commercialization rights in the
U.S., Canada, Australia, New
Zealand, the European Union and European Free Trade
Association countries. Biocon Biologics has exclusive
commercialization rights for Japan
and certain emerging markets. Viatris and Biocon Biologics have
co-exclusive commercialization rights in the rest of the world.
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new
kind of healthcare company, empowering people worldwide to live
healthier at every stage of life. We provide access to medicines,
advance sustainable operations, develop innovative solutions and
leverage our collective expertise to connect more people to more
products and services through our one-of-a-kind Global Healthcare
Gateway®. Formed in November 2020, Viatris brings
together scientific, manufacturing and distribution expertise with
proven regulatory, medical and commercial capabilities to deliver
high-quality medicines to patients in more than 165 countries and
territories. Viatris' portfolio comprises more than 1,400 approved
molecules across a wide range of therapeutic areas, spanning both
non-communicable and infectious diseases, including globally
recognized brands, complex generic and branded medicines, a growing
portfolio of biosimilars and a variety of over-the-counter consumer
products. With a global workforce of approximately 45,000, Viatris
is headquartered in the U.S., with global centers
in Pittsburgh, Shanghai and Hyderabad,
India. Learn more
at viatris.com and investor.viatris.com,
and connect with us on Twitter
at @ViatrisInc, LinkedIn and YouTube.
About Biocon Biologics Limited
Biocon Biologics
Limited, a subsidiary of Biocon Limited, is a fully integrated
global biosimilars organization. It is leveraging cutting-edge
science, innovative tech platforms and advanced research &
development capabilities to lower treatment costs while improving
healthcare outcomes. It has a strong research pipeline of
biosimilar molecules across diabetes, oncology, immunology, and
other non- communicable diseases. Five molecules from Biocon
Biologics' portfolio have been taken from lab to market in
developed markets like United
States, EU, Australia,
Canada and Japan. With a team of ~ 4,800 people, Biocon
Biologics is committed to transforming healthcare and transforming
lives by enabling affordable access to millions of patients'
worldwide.
www.biocon.com/businesses/biosimilars/
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.
Website: www.biocon.com; Follow-us on Twitter: @bioconlimited
Forward-Looking Statements: Viatris
This press release includes statements that constitute
"forward-looking statements." These statements are made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such forward looking statements may include
statements about the approval for the first interchangeable
biosimilar Semglee (insulin glargine-yfgn injection) for the
treatment of diabetes; that interchangeable designation allows
substitution at the pharmacy counter for Lantus® across the U.S. to
help increase access to medicines for people living with diabetes;
that the company is eligible for 12 months of first interchangeable
exclusivity from the date of commercial launch; that this is yet
another important milestone for our company that not only continues
to underscore the strength of our internal scientific capabilities,
but also supports our belief in the promising future of our company
as we continue to work to identify innovative ways to increase
access to complex treatments for patients; that our continued
ability to break down barriers to access, bring forth
first-to-market products and blaze new trails is a testament to the
strength of our scientific, regulatory, operations and legal
expertise as well as our focus on patients; that the
interchangeable Semglee product, which will allow substitution of
Semglee for the reference product, Lantus®, at the pharmacy
counter, will be introduced before the end of the year; that the
company is eligible to have exclusivity for 12 months before the
FDA can approve another biosimilar interchangeable to Lantus; that
commercial preparations for launch are underway; and that over the
next few months, Viatris will transition the current product to the
351(k) interchangeable product. 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 impact
of public health outbreaks, epidemics and pandemics, including the
ongoing challenges and uncertainties posed by the COVID-19
pandemic; the integration of Mylan N.V. and Pfizer Inc.'s Upjohn
business (the "Upjohn Business"), which combined to form Viatris
(the "Combination") and the implementation of our global
restructuring initiatives being more difficult, time consuming or
costly than expected, or being unsuccessful; the ability to achieve
expected benefits, synergies and operating efficiencies in
connection with the Combination or its restructuring initiatives
within the expected timeframe or at all; actions and decisions of
healthcare and pharmaceutical regulators; changes in healthcare and
pharmaceutical laws and regulations in the U.S. and abroad; any
regulatory, legal or other impediments to Viatris' ability to bring
new products to market, including but not limited to "at-risk"
launches; Viatris' or its partners' ability to develop, manufacture
and commercialize products; the scope, timing and outcome of any
ongoing legal proceedings and the impact of any such proceedings;
any significant breach of data security or data privacy or
disruptions to our information technology systems; risks associated
with international operations, including our operations in
China; the ability to protect
intellectual property and preserve intellectual property rights;
changes in third-party relationships; the effect of any changes in
Viatris' or its partners' customer and supplier relationships and
customer purchasing patterns; the impacts of competition; changes
in the economic and financial conditions of Viatris or its
partners; uncertainties and matters beyond the control of
management; and the other risks Viatris' filings with the
Securities and Exchange Commission. Viatris routinely uses its
website as a means of disclosing material information to the public
in a broad, non-exclusionary manner for purposes of the SEC's
Regulation Fair Disclosure (Reg FD). Viatris undertakes no
obligation to update these statements for revisions or changes
after the date of this release other than as required by law.
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 Viatris Inc.