PITTSBURGH and BENGALURU,
India, Nov.
16, 2021 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS)
and Biocon Biologics Ltd. today announced the U.S. launch of
interchangeable biosimilars SEMGLEE® (insulin
glargine-yfgn) injection, a branded product, and Insulin Glargine
(insulin glargine-yfgn) injection, an unbranded product, to help
control high blood sugar in adult and pediatric patients with type
1 diabetes and adults with type 2 diabetes. Both biosimilar
products are available in vial and prefilled pen presentations and
are interchangeable for the reference brand, LANTUS®
(insulin glargine), allowing for substitution at the pharmacy
counter.
Viatris Head of North America Jose Cotarelo said: "Viatris has a
long-standing commitment to improving patient access to
sustainable, quality and more affordable healthcare. We are
extremely proud to stay true to that promise by bringing
to millions of people with diabetes these interchangeable insulin
biosimilar treatment options. We are pleased to also offer a broad
range of options to help patients, which are intended to maximize
access to these important medicines, regardless of financial
circumstances, insurance or channel."
Shreehas Tambe, dCEO, Biocon Biologics said: "At Biocon
Biologics we are committed to expanding access to high-quality,
affordable biologics to patients worldwide. The launch of our
interchangeable biosimilar insulin glargine in the U.S. by our
partner Viatris, is in line with our aspiration to provide our
biosimilar insulins to 'one in five' insulin dependent people with
diabetes, globally. This is indeed a landmark event and along with
the recent formulary listings, we believe it will allow us to
improve accessibility, availability and adoption of biosimilars in
the U.S. for the benefit of patients and the overall healthcare
system."
SEMGLEE (insulin glargine-yfgn) and Insulin Glargine (insulin
glargine-yfgn), co-developed by Viatris and Biocon Biologics,
are now available in the U.S. market. The currently marketed
non-interchangeable SEMGLEE (insulin glargine) is anticipated to be
phased out by the end of the 2021 calendar year.
To further expand access to insulins, Viatris has established a
range of options to help patients, including:
- Patient Assistance Program, which may provide free
medicine to eligible patients with demonstrated financial
need.
- Copay Program offered for eligible commercially-insured
patients, which may help reduce out-of-pocket expenses on
prescriptions to as little as $0 per
30-day supply.
- Voucher for new patients to receive five (5) free 3 mL pens or
two (2) free 10 mL vials.
- Cash-Pay Programs to reduce out-of-pocket costs when
paying at the pharmacy counter.
- Medicare Part D Senior Savings Model Insulin Medicare
Savings Program, with membership beginning in 2022, which
limits patient out-of-pocket costs during all phases of coverage
(deductible, initial coverage and coverage gap) to no more than
$35 for a month's supply.
For more information about SEMGLEE (insulin glargine-yfgn)
and Insulin Glargine (insulin glargine-yfgn) for people
in the U.S., please visit, www.semglee.com.
Indications and Important Safety Information
SEMGLEE
(insulin glargine-yfgn) 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 (insulin glargine-yfgn) 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 (insulin
glargine-yfgn). If hypersensitivity reaction occurs, discontinue
SEMGLEE (insulin glargine-yfgn) 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 38,000, 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
that Viatris and Biocon Biologics today announced the U.S.
launch of interchangeable biosimilars, SEMGLEE® (insulin
glargine-yfgn) injection, a branded product, and Insulin Glargine
(insulin glargine-yfgn) injection, an unbranded product, to help
control high blood sugar in adult and pediatric patients with type
1 diabetes and adults with type 2 diabetes; that both biosimilar
products are available in vial and prefilled pen presentations and
are 'interchangeable for the reference brand, LANTUS®
(insulin glargine), allowing for substitution at the pharmacy
counter; we are pleased to also offer a broad range of options to
help patients, which are intended to maximize access to these
important medicines, regardless of financial circumstances,
insurance or channel; that the currently marketed
non-interchangeable SEMGLEE (insulin glargine) is anticipated to be
phased out by the end of the 2021 calendar year; and information
about the range of options Viatris has established to help
patients, including a patient assistance program, copay program,
voucher, cash-pay programs, and Medicare Part D Senior Savings
Model Insulin Medicare Savings Program. 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 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.