Amneal Enters U.S. Biosimilars Market With Approval of RELEUKOTM (filgrastim-ayow)
March 01 2022 - 4:05PM
Business Wire
- First of three Amneal biosimilars expected for U.S. approval
and launch in 2022
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced the U.S. Food and Drug Administration
(FDA) approval of the Biologics License Application (BLA) for
filgrastim-ayow, a biosimilar referencing Neupogen®. The product
will be marketed under the proprietary name RELEUKOTM.
RELEUKOTM 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. Amneal expects to launch RELEUKOTM in the
third quarter of 2022, along with a full patient support
program.
The Company is planning for a pegfilgrastim biosimilar
referencing Neulasta® and a bevacizumab biosimilar referencing
Avastin® to launch in 2022. Both are being reviewed by the FDA.
“The U.S. approval of our first biosimilar is a very significant
milestone for Amneal. Biosimilars represent the next wave of
providing access to affordable medicines in the U.S. We are
building a global biosimilars business by leveraging partner assets
to start and then leveraging our own key capabilities over time.
Our goal is to become a meaningful long-term player in
biosimilars,” said Chirag and Chintu Patel, Co-Chief Executive
Officers.
“It is a proud moment for the Kashiv Biosciences team and our
partners at Amneal to have our first biosimilar, RELEUKO™, approved
by the U.S. FDA. Kashiv is one of a few domestic companies to
manufacture and launch a biosimilar 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 filgrastim for the 12
months ended December 2021 were $407 million, of which $275 million
represents biosimilar sales.
RELEUKOTM in the U.S. is indicated:
- To decrease the incidence of infection‚ as manifested by
febrile neutropenia‚ in patients with nonmyeloid malignancies
receiving myelosuppressive anti- cancer drugs associated with a
significant incidence of severe neutropenia with fever.
- To reduce the time to neutrophil recovery and the duration of
fever, following induction or consolidation chemotherapy treatment
of patients with acute myeloid leukemia (AML).
- To reduce the duration of neutropenia and neutropenia-related
clinical sequelae‚ e.g., febrile neutropenia, in patients with
nonmyeloid malignancies undergoing myeloablative chemotherapy
followed by bone marrow transplantation (BMT).
- To reduce the incidence and duration of sequelae of severe
neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in
symptomatic patients with congenital neutropenia‚ cyclic
neutropenia‚ or idiopathic neutropenia.
RELEUKOTM IMPORTANT SAFETY INFORMATION
Patients with a history of serious allergic reactions to human
granulocyte colony-stimulating factors such as filgrastim products
or pegfilgrastim products.
Before you take RELEUKOTM, 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 for
ARDS. Discontinue RELEUKOTMin patients with ARDS.
- Fatal sickle cell crises: Serious sickle cell crises have been
reported in patients with sickle cell disorders receiving
RELEUKOTM. Discontinue RELEUKOTMif sickle cell crisis occurs.
- Serious allergic reactions, including anaphylaxis: Permanently
discontinue RELEUKOTM in patients with serious allergic
reactions.
- Kidney injury (Glomerulonephritis): Kidney injury have been
reported in patients on RELEUKOTM. Consider dose-reduction or
interruption of RELEUKOTMin patients with kidney injury.
- Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia
(AML): Monitor patients with breast and lung cancer using
RELEUKOTMin conjunction with chemotherapy and/or radiotherapy for
signs and symptoms of MDS/AML.
- Decreased platelet count (thrombocytopenia); increased white
blood cell count (leukocytosis) and inflammation of your blood
vessels (cutaneous vasculitis) have been reported. Monitor platelet
counts and white blood cell count.
ADVERSE REACTIONS
Most common adverse reactions in patients:
- With nonmyeloid malignancies receiving myelosuppressive
anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
- With AML are pain, epistaxis and rash.
- With nonmyeloid malignancies undergoing myeloablative
chemotherapy followed by Bone Marrow Transplant is rash.
- With severe chronic neutropenia are pain, anemia, epistaxis,
diarrhea, hypoesthesia and alopecia
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; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220301006066/en/
Anthony DiMeo Senior Director, Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Amneal Pharmaceuticals (NYSE:AMRX)
Historical Stock Chart
From Apr 2023 to Apr 2024