- Marks Amneal’s third biosimilar approval in 2022
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced that the U.S. Food and Drug
Administration (“FDA”) has approved the Company’s Biologics License
Application (“BLA”) for pegfilgrastim-pbbk, a biosimilar
referencing Neulasta®. The product will be marketed under the
proprietary name FYLNETRA™.
FYLNETRA was developed in collaboration with Kashiv Biosciences,
LLC, located in Chicago, Illinois. It is used to treat neutropenia
(low neutrophils which are a type of white blood cells that fight
infection) which is commonly experienced by patients undergoing
chemotherapy.
This marks the third biosimilar approval Amneal received this
year for products used in oncology, the second-largest biosimilar
category in the U.S. Earlier this year, Amneal received approval of
Releuko® (filgrastim-ayow), a filgrastim biosimilar referencing
Neupogen®, and Alymsys® (bevacizumab-maly), a bevacizumab
biosimilar referencing Avastin®. Amneal expects to launch these
three products over the second half of 2022, along with a full
patient support program.
“This is our third U.S. biosimilar approval this year and we are
very enthusiastic about our future in the fast growing $28 billion
U.S. biosimilars market. Biosimilars represent the next wave of
affordable medicines and are closely aligned with our mission to
provide high quality, affordable medicines to as many patients as
possible,” said Chirag and Chintu Patel, Co-Chief Executive
Officers.
“Building on our successful partnership with the recent approval
of our first biosimilar, Releuko, we are pleased to receive
approval for our second biosimilar. Kashiv is one of a few domestic
companies to manufacture and launch multiple biosimilars in the
United States. Kashiv aims to continue bringing high quality
biosimilars to the global markets over the coming years. I would
like to extend a humble thank you to our highly talented team,
without whom this would not have been possible,” said Dr.
Chandramauli Rawal, Chief Operating Officer for Kashiv.
According to IQVIA®, U.S. annual sales for pegfilgrastim for the
12 months ended March 2022 were $3.1 billion, $1.0 billion of which
represented biosimilar sales.
Indications: FYLNETRA is a leukocyte growth factor
indicated to decrease the incidence of infection, as manifested by
febrile neutropenia, in patients with non-myeloid malignancies
receiving myelosuppressive anti-cancer drugs associated with a
clinically significant incidence of febrile neutropenia.
Limitations of Use: FYLNETRA is not indicated for the
mobilization of peripheral blood progenitor cells for hematopoietic
stem cell transplantation.
FYLNETRA IMPORTANT SAFETY INFORMATION
FYLENTRA is contraindicated in patients with a history of
serious allergic reactions to human granulocyte colony-stimulating
factors such as filgrastim products or pegfilgrastim products.
Before you take FYLNETRA, tell your healthcare provider if you
are pregnant or plan to breast feed, and if you have sickle cell
disorder, kidney problems or receiving radiation therapy.
WARNINGS AND PRECAUTIONS
- Fatal splenic rupture: Patients may experience enlarged spleen
which can rupture and cause death.
- Acute respiratory distress syndrome (ARDS): Patients may
develop fever and lung infiltrates or respiratory distress.
Discontinue FYLNETRA in patients with ARDS.
- Fatal sickle cell crises: Serious sickle cell crises have been
reported in patients with sickle cell disorders receiving FYLNETRA.
Discontinue FYLNETRA if sickle cell crisis occurs.
- Serious allergic reactions, including anaphylaxis: Permanently
discontinue FYLNETRA in patients with serious allergic
reactions.
- Kidney injury (Glomerulonephritis): Kidney injury have been
reported in patients on FYLNETRA. Consider dose-reduction or
interruption of FYLNETRA in patients with kidney injury.
- Decreased platelet count (thrombocytopenia); and increased
white blood cell count (leukocytosis) have been reported. Monitor
platelet counts and white blood cell count.
- Capillary leak syndrome has been reported after G-CSF
administration, including pegfilgrastim products, and is
characterized by hypotension, hypoalbuminemia, edema and
hemoconcentration.
- The possibility that pegfilgrastim products act as a growth
factor for any tumor type, including myeloid malignancies and
myelodysplasia, diseases for which pegfilgrastim products are not
approved, cannot be excluded.
- Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia
(AML): Monitor patients with breast and lung cancer using FYLNETRA
in conjunction with chemotherapy and/or radiotherapy for signs and
symptoms of MDS/AML.
- Aortitis has been reported in patients receiving pegfilgrastim
products.
- Increased hematopoietic activity of the bone marrow in response
to growth factor therapy has been associated with transient
positive bone imaging changes.
ADVERSE REACTIONS
Most common adverse reactions (≥ 5% difference in incidence
compared to placebo) are bone pain and pain in extremity.
For full prescribing information, see package insert located
here.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is a fully integrated essential medicines company.
We make healthy possible through the development, manufacturing,
and distribution of generic and specialty pharmaceuticals,
primarily within the United States. The Company has a diverse
portfolio of over 250 products in its Generics segment and is
expanding across a broad range of complex products and therapeutic
areas, including injectables and biosimilars. In its Specialty
segment, Amneal has a growing portfolio of branded pharmaceutical
products focused primarily on central nervous system and endocrine
disorders, with a pipeline focused on unmet needs. Through its
AvKARE segment, the Company is a distributor of pharmaceuticals and
other products for the U.S. federal government, retail, and
institutional markets. For more information, please visit
www.amneal.com.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are
not historical facts, may be forward-looking statements (as defined
in the U.S. Private Securities Litigation Reform Act of 1995). Such
forward-looking statements include statements about FLYNETRA
(pegfilgrastim-pbbk), including its potential benefits,
management’s intentions, plans, beliefs, expectations or forecasts
regarding FLYNETRA and other products, including among other
things: product research and development; discussions of future
operations; expected operating results and financial performance,
including potential future revenues from FLYNETRA and other
products; the Company’s strategy for growth; regulatory actions;
market position and expenditures. Words such as “plans,” “expects,”
“will,” “anticipates,” “estimates” and similar words are intended
to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking
statements. These forward-looking statements are based on current
expectations of future events. If the underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of the Company.
Such risks and uncertainties include, but are not limited to:
our ability to successfully develop, license, acquire and
commercialize new products on a timely basis, including the risks
and uncertainties regarding the launch timing and commercial
success of FLYNETRA; the competition we face in the pharmaceutical
industry in general, including the potential approval of additional
biosimilar versions of pegfilgrastim; our ability to obtain
exclusive marketing rights for our products; our ability to manage
our growth through acquisitions and otherwise; our dependence on
the sales of a limited number of products for a substantial portion
of our total revenues; the continuing trend of consolidation of
certain customer groups; our dependence on third-party suppliers
and distributors for raw materials for our products and certain
finished goods and any associated supply chain disruptions;
litigation outcomes, including intellectual property disputes or
other legal efforts to prevent or limit Amneal from selling its
products; the impact of severe weather; the impact of the ongoing
COVID-19 pandemic; risks related to federal regulation of
arrangements between manufacturers of branded and generic products;
our reliance on certain licenses to proprietary technologies from
time to time; the significant amount of resources we expend on
research and development; the risk of product liability and other
claims against us by consumers and other third parties; risks
related to changes in the regulatory environment, including U.S.
federal and state laws related to healthcare fraud abuse and health
information privacy and security and changes in such laws; changes
to FDA product approval requirements; the impact of healthcare
reform and changes in coverage and reimbursement levels by
governmental authorities and other third-party payers; our
dependence on third-party agreements for a portion of our product
offerings; the impact of global economic conditions, including any
economic effects stemming from adverse geopolitical events, an
economic downturn and inflation rates; our ability to identify,
make and integrate acquisitions or investments in complementary
businesses and products on advantageous terms; our substantial
amount of indebtedness and our ability to generate sufficient cash
to service our indebtedness in the future, and the impact of
interest rate fluctuations on such indebtedness; our obligations
under a tax receivable agreement may be significant; and the high
concentration of ownership of our Class A Common Stock and the fact
that we are controlled by the Amneal Group. The forward-looking
statements contained herein are also subject generally to other
risks and uncertainties that are described from time to time in the
Company’s filings with the Securities and Exchange Commission,
including under Item 1A, “Risk Factors” in the Company’s most
recent Annual Report on Form 10-K and in its subsequent reports on
Forms 10-Q and 8-K. Investors are cautioned not to place undue
reliance on any such forward-looking statements, which speak only
as of the date they are made. Forward-looking statements included
herein speak only as of the date hereof and we undertake no
obligation to revise or update such statements to reflect the
occurrence of events or circumstances after the date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20220527005044/en/
Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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