Pegfilgrastim Biosimilar Gets FDA Approval


Pegfilgrastim-jmdb is the first biosimilar to pegfilgrastim (Neulasta) approved by the FDA.

The FDA has approved pegfilgrastim-jmdb (Fulphila, Mylan GmbH) as the first biosimilar to pegfilgrastim (Neulasta). The drug is used to decrease the chance of infection, with fever, associated with an abnormally low number of infection-fighting white blood cells in patients with nonbone marrow 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 can reduce drug costs and promote access,” said FDA Commissioner Scott Gottlieb, MD, 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’s approval of pegfilgrastim-jmdb is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates that pegfilgrastim-jmdb is biosimilar to pegfilgrastim. Pegfilgrastim-jmdb has been approved as a biosimilar, not as an interchangeable product.

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