The FDA has approved filgrastim-laha (FILKRI), a biosimilar to filgrastim (NEUPOGEN), for patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients with severe chronic neutropenia, and patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).
The filgrastim-laha FDA approval is based on studies demonstrating biosimilarity to filgrastim in pharmacokinetics, pharmacodynamics, safety, and immunogenicity, according to the manufacturer from Accord Biopharma. Filgrastim-laha is contraindicated in patients with serious allergic reactions to human G-CSF products. By regulating neutrophil production within the bone marrow and accelerating recovery, these G-CSF options help reduce the duration of neutropenia, according to a press release by Accord BioPharma.
The company expects a permanent Q-code from CMS for billing and reimbursement, it said in the release.
