FDA Approves Releuko (filgrastim-ayow), a Biosimilar to Neupogen
February 28, 2022 -- The United States (U.S.) Food and Drug Administration (FDA) has approved Releuko (filgrastim-ayow), a biosimilar to Neupogen (filgrastim).
The FDA approval was based on a review of data that demonstrated a high degree of similarity of Releuko compared to its reference product Neupogen.
In the U.S., 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.
- Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
- 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).
- 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.
Releuko (filgrastim-ayow) is the third biosimilar to Neupogen to be approved by the FDA after Zarxio (filgrastim-sndz) and Nivestym (filgrastim-aafi).
Releuko will be distributed by Amneal Biosciences, LLC.
Posted: February 2022