FDA Approves Filgrastim-ayow, First Biosimilar from Amneal

Officials with the FDA have approved filgrastim-ayow (Releuko; Amneal) as a biosimilar referencing filgrastim (Neupogen, Amgen) for the treatment of neutropenia, according to a press release.

The approval marks the first biosimilar for Amneal, with 2 more decisions expected by the end of the year. It is expected to launch in the third quarter of 2022, along with a full patient support program.

“The US approval of our first biosimilar is a very significant milestone for Amneal,” said Chirag and Chintu Patel, co-chief executive officers at Amneal, in the press release. “Biosimilars represent the next wave of providing access to affordable medicines in the US.”

Filgrastim-ayow has several indications, including to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. It is also indicated to reduce the time to neutrophil recovery and the duration of fever, to reduce the duration of neutropenia and neutropenia-related clinical sequelae, and to reduce the incidence and duration of sequelae of severe neutropenia.

The drug has significant warnings and precautions, including for fatal splenic rupture, acute respiratory distress syndrome, allergic reactions including anaphylaxis, glomerulonephritis, myelodysplastic syndrome, and thrombocytopenia. Serious sickle cell crises have also been reported among patients with sickle cell disorders receiving filgrastim-ayow.

The most common adverse events (AEs) among patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea. AEs among patients with acute myeloid leukemia include pain, epistaxis, and rash.

The most common AE among patients with non-myeloid malignancies who are undergoing myeloablative chemotherapy followed by bone marrow transplant is rash. Finally, patients with severe chronic neutropenia most commonly experienced pain, anemia, epistaxis, diarrhea, hypoesthesia, and alopecia.

REFERENCE

Amneal Enters US Biosimilars Market With Approval of Releuko (filgrastim-ayow). News release. Amneal; March 1, 2022. Accessed March 3, 2022. https://www.businesswire.com/news/home/20220301006066/en