Biosimilar Releuko Gets FDA Approval
The Food and Drug Administration (FDA) has approved Releuko™ (filgrastim-ayow), a biosimilar to Neupogen® (filgrastim). The approval was 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 2 agents.
Releuko, a leukocyte growth factor, is approved 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.
Releuko is supplied in single-dose vials and single-dose prefilled syringes containing 300mcg or 480mcg of filgrastim-ayow in a preservative-free solution. The product is expected to be available in the third quarter of 2022.
References
Amneal enters US biosimilars market with approval of ReleukoTM (filgrastim-ayow). News release. March 2, 2022.
https://www.businesswire.com/news/home/20220301006066/en/Amneal-Enters-U.S.-Biosimilars-Market-With-Approval-of-RELEUKOTM-filgrastim-ayow
Releuko. Package insert. Amneal. Accessed March 2, 2022. https://www.amneal.com/wp-content/uploads/2022/03/Releuko-Prescribing-Information.pdf
https://www.empr.com/home/news/biosimilar-releuko-gets-fda-approval/
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