FDA Approves First Biosimilar to Pegfilgrastim to Help Reduce the Risk of Infection During Myelosuppressive Chemotherapy

June 5, 2018 – On June 4, the U.S. Food and Drug Administration (FDA) approved pegfilgrastim-jmdb as the first biosimilar to pegfilgrastim to decrease the chance of infection as suggested by febrile neutropenia in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy that has 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 … (leggi tutto)