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JUNE 4, 2018

FDA Approves Fulphila, First Biosimilar to Neulasta

By PPN News Staff

The FDA approved pegfilgrastim-jmdb (Fulphila, Mylan) as the first biosimilar to pegfilgrastim (Neulasta, Amgen) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast.