Releuko® (filgrastim-ayow), a biosimilar to Neupogen® (filgrastim), is now available in the US for the treatment of neutropenia.

Releuko, a leukocyte growth factor, 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.
  • Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia.
  • Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation.
  • Reduce the incidence and duration of sequelae of neutropenia in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

The Food and Drug Administration (FDA) approved Releuko in March 2022 based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents. 

Releuko is supplied in single-dose vials and single-dose prefilled syringes containing 300mcg or 480mcg of filgrastim-ayow in a preservative-free solution. 

Reference

Amneal launches second biosimilar with Releuko® (filgrastim-ayow) in the United States. News release. Amneal Pharmaceuticals, Inc. Accessed November 23, 2022. https://www.businesswire.com/news/home/20221122005327/en/Amneal-Launches-Second-Biosimilar-with-RELEUKO%C2%AE-filgrastim-ayow-in-the-United-States.