On June 4, 2018, pegfilgrastim-jmdb (Fulphila) was approved as a biosimilar to pegfilgrastim (Neulasta) to decrease infection risk in patients with nonmyeloid cancer receiving myelosuppressive chemotherapy associated with a significant incidence of febrile neutropenia.1,2
Approval Basis
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.
Biosimilar indicates that the biologic product is highly similar to a U.S. Food and Drug Administration–approved biologic reference product and that there are no clinically meaningful differences between the biosimilar product and the reference product with regard to safety, purity, and potency (safety and effectiveness). This is generally demonstrated through human pharmacokinetic (exposure) and pharmacodynamic (response) studies, an assessment of clinical immunogenicity, and, if needed, additional clinical studies.
An interchangeable product is a biosimilar product that meets additional requirements, including demonstration that the product is expected to produce the same clinical result as the reference product in any given patient. For products administered to a patient more than once, the risk in terms of safety and reduced efficacy of switching back and forth between an interchangeable product and a reference product requires evaluation. An interchangeable product may be substituted for the reference product without involvement of the prescriber.
Safety Profile
The most common adverse events observed with pegfilgrastim with ≥ 5% difference in incidence compared to placebo are bone pain and pain in extremity. 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 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.
As with pegfilgrastim, pegfilgrastim-jmdb carries warnings/precautions for fatal splenic rupture, acute respiratory distress syndrome, serious allergic reactions, including anaphylaxis, fatal sickle cell crises, and glomerulonephritis. ■
REFERENCES
1. U.S. Food and Drug Administration: FDA approves first biosimilar to Neulasta to decrease the risk of infection during cancer treatment. Available at www.fda.gov. Accessed June 14, 2018.
2. Fulphila (pegfilgrastim-jmdb) injection for subcutaneous use prescribing information, Mylan GmbH, June 2018. Available at www.accessdata.fda.gov/drugsatfda_docs/label/2018/761075s000lbl.pdf. Accessed June 14, 2018.
