FDA Approves Fulphila, First Biosimilar Pegfilgrastim

June 5, 2018

Biosimilars Team

The Food and Drug Administration (FDA) has approved Fulphila (pegfilgrastim-jmdb; Mylan), the first biosimilar pegfilgrastim (Neulasta; Amgen). Pegfilgrastim is a leukocyte growth factor administered by subcutaneous injection 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.

Fulphila is not approved as an interchangeable product.

Fulphila was co-developed by Mylan and Biocon. Mylan anticipates launching Fulphila in the coming weeks; a suite of patient services will be available to further support patients and caregivers with treatment.