FDA approves first biosimilar to pegfilgrastim to help reduce the risk of infection during cancer treatment
FDA has approved pegfilgrastim-jmdb (Fulphila—Mylan) as a biosimilar to pegfilgrastim (Neulasta—Amgen).
FDA has approved pegfilgrastim-jmdb (Fulphila—Mylan) as a biosimilar to pegfilgrastim (Neulasta—Amgen). Pegfilgrastim-jmdb is approved to reduce the risk of infection as indicated by febrile neutropenia in individuals with non-myeloid cancer who are undergoing myelosuppressive chemotherapy with a clinically significant incidence of febrile neutropenia. "Bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access," said FDA Commissioner Scott Gottlieb, MD. The agency based its approval of pegfilgrastim-jmdb on a review of evidence including extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, and clinical immunogenicity data. FDA noted the most frequent adverse effects from pegfilgrastim-jmdb are bone pain and pain in the extremities. Serious adverse events from treatment include rupture of the spleen, acute respiratory distress syndrome, serious allergic reactions, glomerulonephritis, leukocytosis, and the potential for tumor growth. FDA also noted there have been fatal sickle cell crises.