Amneal Pharmaceuticals, Inc 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 USD, of which 272 million USD represented biosimilar sales.
About RELEUKO
• 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.
