Amneal Pharmaceuticals, Inc. 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.