The U.S. Food and Drug Administration has approved the first biosimilar to pegfilgrastim (Neulasta, Amgen), a granulocyte colony-stimulating factor used to reduce infection risk in patients with cancer.
The new product is pegfilgrastim-jmdb ( Fulphila , Mylan GmbH), approved for use to decrease the risk for infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
"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, in a press statement.
"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," he added.
The FDA's approval of pegfilgrastim-jmdb is based on review of evidence that does not include randomized clinical trial data. Instead the evidence consists of structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.
The most common side effects of pegfilgrastim-jmdb are bone pain and pain in extremities, according to the FDA.
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as pegfilgrastim or filgrastim products, should not receive pegfilgrastim-jmdb.
Serious side effects from treatment 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. Deaths due to sickle cell crises have occurred with the product.
The FDA will release a comprehensive new plan to advance new policy efforts that promote biosimilar product development later this summer as part of a cost control initiative.
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Cite this: FDA Approves Pegfilgrastim Biosimilar for Cancer Infection Risk - Medscape - Jun 04, 2018.