Amneal Launches Second Biosimilar with RELEUKO® (filgrastim-ayow) in the United States
November 22 2022 - 4:05PM
Business Wire
Second of three approved U.S. oncology biosimilars Amneal
expects to launch
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced the commercial launch of RELEUKO®
(filgrastim-ayow), a biosimilar referencing Neupogen®. RELEUKO® is
used to treat neutropenia which is commonly experienced by patients
undergoing chemotherapy. This product was developed in
collaboration with Kashiv Biosciences, LLC located in Chicago,
Illinois.
“RELEUKO is our second U.S. biosimilar launch and represents the
next step in building out our biosimilars business. This product is
another important oncology therapeutic offering for providers and
their patients as we look to make essential medicines more
accessible for all,” said Harsher Singh, SVP of Amneal Biosciences
division.
According to IQVIA®, U.S. annual sales for filgrastim for the 12
months ended August 2022 were $390 million, of which $272 million
represented biosimilar sales.
About RELEUKO
RELEUKO® 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.
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 RELEUKO®, 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 RELEUKO® in patients with ARDS.
- Fatal sickle cell crises: Serious sickle cell crises have been
reported in patients with sickle cell disorders receiving RELEUKO®.
Discontinue RELEUKO® if sickle cell crisis occurs.
- Serious allergic reactions, including anaphylaxis: Permanently
discontinue RELEUKO® in patients with serious allergic
reactions.
- Kidney injury (Glomerulonephritis): Kidney injury have been
reported in patients on RELEUKO®. Consider dose-reduction or
interruption of RELEUKO® in patients with kidney injury.
- Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia
(AML): Monitor patients with breast and lung cancer using RELEUKO®
in 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 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, please visit www.amneal.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20221122005327/en/
Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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