Amneal is introducing Releuko (filgrastim-ayow), a biosimilar of Amgen's Neupogen.
Releuko, used to treat neutropenia commonly experienced by patients undergoing chemotherapy, was developed in collaboration with Kashiv Biosciences.
[Read more: FDA approves biosimilar Neupogen]
“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, senior vice president of Amneal Biosciences division.
Filgrastim had a market value of $390 million, of which $272 million represented biosimilar sales for the 12 months ending August 2022, according to IQVIA.
[Read more: Amneal debuts 2 generics]
Releuko 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;
- 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; and
- 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.