FDA approves first biosimilar to pegfilgrastim


The Food and Drug Administration has approved pegfilgrastim-jmdb as the first biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.

The approval is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates pegfilgrastim-jmdb is biosimilar to pegfilgrastim, the FDA said in a statement.

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The most common side effects of pegfilgrastim-jmdb are bone pain and pain in extremities. Serious side effects include spleen rupture, acute respiratory distress syndrome, serious allergic reactions including anaphylaxis, glomerulonephritis, leukocytosis, capillary leak syndrome, and tumor growth potential. Fatal sickle cell crises have occurred.

The FDA warns that “patients with a history of serious allergic reactions to human granulocyte colony–stimulating factors such as pegfilgrastim or filgrastim products should not take pegfilgrastim-jmdb.”

This approval is part of the FDA’s efforts to “help promote competition that can reduce drug costs and promote access,” FDA commissioner Scott Gottlieb, MD, said in the statement. “This summer, we’ll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development. Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”

Pegfilgrastim-jmdb will be marketed as Fulphila by Mylan GmbH.

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