- Marks the second of three biosimilars Amneal expects to
receive U.S. approval for 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 bevacizumab-maly, a biosimilar referencing
Avastin®. The product will be marketed under the proprietary name
ALYMSYS® and represents the third bevacizumab biosimilar approved
in the U.S.
ALYMSYS® was developed by mAbxience, a global biotech company
with over a decade of experience in the development, manufacture,
and commercialization of biopharmaceuticals. Bevacizumab-maly is a
vascular endothelial growth factor inhibitor used in oncology. This
marks the second of three biosimilars approvals Amneal expects to
receive this year 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 the Company’s pegfilgrastim biosimilar referencing
Neulasta® is currently under review by the FDA.
“With the U.S. approval of our second biosimilar, ALYMSYS®, we
are continuing our momentum and establishing our presence in the
$28 billion U.S. biosimilars market. By combining partner assets
with our own key capabilities, we are on a clear path to becoming a
meaningful player in this high growth category. Biosimilars
represent the next wave of affordable medicines in the U.S. and are
closely aligned with our strategy to provide high quality,
affordable medicines to as many patients as possible,” said Chirag
and Chintu Patel, Co-Chief Executive Officers.
“Through our strategic partnership with a market leader like
Amneal, we are excited to see this important product enter the U.S.
biosimilar market. For us, this is a great example of our
globalization strategy materializing and how innovation and
cutting-edge R&D technology can be applied to create high
quality, affordable medicines that improve access to critical
treatments,” said Emmanuelle Lepine, Chief Executive Officer of
mAbxience.
According to IQVIA®, U.S. annual sales for bevacizumab for the
12 months ended February 2022 were $2.6 billion, $1.6 billion of
which represented biosimilar sales.
ALYMSYS® (bevacizumab-maly) in the U.S. is a vascular
endothelial growth factor inhibitor indicated for the treatment
of:
- Metastatic colorectal cancer, in combination with intravenous
fluorouracil-based chemotherapy for first or second-line
treatment.
- Metastatic colorectal cancer, in combination with
fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based
chemotherapy for second-line treatment in patients who have
progressed on a first-line bevacizumab product-containing
regimen.
- First-Line non-squamous non-small cell lung cancer, in
combination with carboplatin and paclitaxel.
- Recurrent glioblastoma in adults.
- Metastatic renal cell carcinoma in combination with interferon
alfa.
- Persistent, recurrent, or metastatic cervical cancer, in
combination with paclitaxel and cisplatin or paclitaxel and
topotecan.
- Epithelial ovarian, fallopian tube, or primary peritoneal
cancer, in combination with paclitaxel
Limitations of Use: ALYMSYS® is not indicated for
adjuvant treatment of colon cancer.
ALYMSYS® IMPORTANT SAFETY INFORMATION includes warnings
and precautions on severe and fatal hemorrhage; arterial and venous
thromboembolic events; hypertension, hypertensive crisis, and
hypertensive encephalopathy; renal injury, proteinuria, and
nephrotic syndrome; posterior reversible encephalopathy syndrome;
embryo-fetal toxicity; ovarian failure; congestive heart failure;
gastrointestinal perforations and fistula; surgery and wound
healing complications, and infusion-related reactions.
ADVERSE REACTIONS
Reported adverse drug reactions in patients include epistaxis,
hemorrhage, hypertension, exfoliative dermatitis, proteinuria, back
pain, headache, rhinitis, taste alteration, dry skin, and
lacrimation disorder.
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 approximately 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, 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 regarding
management’s intentions, plans, beliefs, expectations or forecasts
for the future, including among other things: product research and
development; discussions of future operations; expected operating
results and financial performance; the Company’s strategy for
growth; regulatory approvals; 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 risks and
uncertainties regarding the launch timing and commercial success of
ALYMSYS® and other biosimilar products; the competition we face in
the pharmaceutical industry from brand and generic drug product
companies; the impact of global economic conditions; direct or
indirect impacts of the ongoing COVID-19 pandemic; our ability to
obtain exclusive marketing rights for our products; the impact of
competition on our ability to set prices; 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 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; risks related to federal regulation
of arrangements between manufacturers of branded and generic
products; the impact of healthcare reform and changes in coverage
and reimbursement levels by governmental authorities and other
third-party payers; the continuing trend of consolidation of
certain customer groups; our reliance on certain licenses to
proprietary technologies from time to time; our dependence on
third-party suppliers and distributors for raw materials for our
products and certain finished goods; our dependence on third-party
agreements for a portion of our product offerings; our ability to
identify, make and integrate acquisitions or investments in
complementary businesses and products on advantageous terms; legal,
regulatory and legislative efforts by our brand competitors to
deter competition from our generic alternatives; the significant
amount of resources we expend on research and development; 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; and the
impact of severe weather. 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/20220413005966/en/
Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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