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Amneal Launches Second Biosimilar with RELEUKO® (filgrastim-ayow) in the United States
Second of three approved U.S. oncology biosimilars Amneal expects to launch BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX)
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\nSecond of three approved U.S. oncology biosimilars Amneal expects to launch\n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal 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.\n\n“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.\n\nAccording 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.\n\nAbout RELEUKO\n\nRELEUKO® in the U.S. is indicated:\n\n\nTo 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.\n\n\nTo reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).\n\n\nTo 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).\n\n\nTo 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.\n\n\nIMPORTANT SAFETY INFORMATION\n\nPatients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.\n\nBefore 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.\n\nWARNINGS AND PRECAUTIONS\n\n\nFatal...