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FDA approves Fulphila, first Neulasta biosimilar, to prevent infection during cancer treatment
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The FDA approved Fulphila, the first biosimilar to pegfilgrastim, to decrease risk for infection, as suggested by febrile neutropenia, among patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy.
Fulphila (pegfilgrastim-jmdb, Mylan GmbH) is a biologic product, meaning it is derived from a living organism such as humans, animals, microorganisms or yeast. Biosimilars must show no clinically meaningful differences in safety, purity and potency from its reference product.
“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “We’ll continue to prioritize reviews of these products to help ensure that biosimilar medications are brought to the market efficiently and through a process that makes certain that these new medicines meet the FDA’s rigorous standard for approval.”
The FDA based this approval on review of evidence — including extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data — showing pegfilgrastim-jmdb is biosimilar to pegfilgrastim (Neulasta, Amgen).
The most common side effects of pegfilgrastim-jmdb include bone pain and pain in extremities. Serious side effects from treatment with pegfilgrastim-jmdb include rupture of the spleen; acute respiratory distress syndrome; serious allergic reactions, including anaphylaxis; glomerulonephritis; leukocytosis; capillary leak syndrome; and the potential for tumor growth.
Researchers also have observed fatal sickle cell crises.