FDA Press Release: FDA approves biosimilar, Fulphila (pegfilgrastim-jmdb)

Press Announcements > FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment


FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment

The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. Continue reading...