Biosimilar to Pegfilgrastim

On June 4, 2018, the U.S. Food and Drug Administration (FDA) approved pegfilgrastim-jmdb (Fulphila) as a biosimilar to pegfilgrastim (Neulasta) 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.

Healthcare 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 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. 

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.

In collaboration with the FDA and as a service to our members, ONS provides updates on recent FDA approvals and other important FDA actions (e.g., updated safety information, new prescribing information) pertaining to therapies for patients with cancer. This allows the agency to inform oncologists and professionals in oncology-related fields in a timely manner. Included in the FDA updates is a link to the product label or to other sites for additional relevant clinical information. In supplying this information, ONS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

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