FDA Approves First Biosimilar to Neulasta to Decrease the Risk of Infection During Cancer Treatment

June 6, 2018

On June 4, 2018, the Food and Drug Administration approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH) as a biosimilar to Neulasta (pegfilgrastim, Amgen, Inc.) 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.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

The approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity, and other clinical safety and effectiveness data demonstrating that Fulphila is biosimilar to Neulasta. Fulphila has been approved as a biosimilar, not as an interchangeable product.

The most common side effects of Fulphila 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 Fulphila. Serious side effects from treatment with Fulphila 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.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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