Filkri (filgrastim-laha) / Intas - LARVOL DELTA

FDA Approves FILKRI (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN (filgrastim) (PRNewswire) - "...Approved...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)....FILKRI was approved based on two randomized studies in healthy adults, with pharmacokinetics (PK)/pharmacodynamics (PD) assessed in one study and safety and immunogenicity evaluated in both, compared with reference product NEUPOGEN."

FDA approval • Neutropenia