The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), for use in cancer patients at risk of infection due to chemotherapy.
Filkri is indicated for patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia undergoing induction or consolidation therapy, bone marrow transplant recipients, individuals with severe chronic neutropenia and patients exposed to myelosuppressive radiation.
The biosimilar marks the sixth FDA-approved product in Accord BioPharma’s biosimilar portfolio and the seventh overall, according to a Feb. 17 news release. It complements the company’s long-acting G-CSF biosimilar Udenyca (pegfilgrastim-cbqv), creating a full portfolio of granulocyte colony-stimulating factor options.
Fikri’s approval was supported by two randomized studies in healthy adults that demonstrated comparable pharmacokinetics, pharmacodynamics, safety and immunogenicity to Neupogen. The product is contraindicated in patients with serious allergic reactions to filgrastim or pegfilgrastim.
Leave a Reply