On February 17, 2026, the U.S. Food and Drug Administration (FDA) approved FILKRI (filgrastim-laha), a biosimilar to Amgen’s NEUPOGEN (filgrastim). FILKRI was developed by Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals Ltd.
FILKRI is indicated for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia (AML) receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients with severe chronic neutropenia; and patients exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). FILKRI is a granulocyte colony-stimulating factor (G-CSF) and functions as a growth factor that stimulates the production of neutrophils in the bone marrow.
The approval of FILKRI was based on two randomized studies conducted in healthy adults. The data demonstrated that FILKRI showed no clinically meaningful differences compared to NEUPOGEN in pharmacokinetics (PK) and pharmacodynamics (PD) parameters, as well as in safety and immunogenicity profiles.
FILKRI expands Accord BioPharma’s oncology supportive care offerings alongside UDENYCA (pegfilgrastim-cbqv), a biosimilar to Amgen’s NEULASTA. The company also markets additional biosimilars, including products referencing STELARA, HERCEPTIN, PROLIA, and XGEVA.
FILKRI is the fifth biosimilar filgrastim product to be approved by FDA.
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