FDA Approves Biosimilar to Pegfilgrastim to Reduce Risk of Infection During Myelosuppressive Chemotherapy


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On June 4, the U.S. Food and Drug Administration (FDA) approved pegfilgrastim-jmdb (Fulphila) as the first biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection as suggested by febrile neutropenia in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

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“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. “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. 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.”

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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 pegfilgrastim-jmdb is biosimilar to pegfilgrastim. Pegfilgrastim-jmdb has been approved as a biosimilar, not as an interchangeable product.

The most common side effects of pegfilgrastim-jmdb are bone pain and pain in extremities. 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.

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. Fatal sickle cell crises have occurred.

The FDA granted approval of Fulphila to Mylan GmbH. ■


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