FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or misleading promotional communications about the product’s benefit
The Food and Drug Administration (FDA) has issued an untitled letter to Amgen Inc. for the misbranding of its biological product, Neulasta (pegfilgrastim) injection, for subcutaneous use, resulting from a false or misleading promotional communication.
Amgen Inc. released a promotional communication that makes false or misleading claims and representations about the benefit of Neulasta when administered through the Onpro on-body injector compared to a prefilled syringe. Neulasta is the reference product for all FDA-licensed biosimilar pegfilgrastim products, which are only available as a prefilled syringe.
Amgen’s promotional communication cites an observational study and makes claims and presentations based on that study that create a misleading impression about the benefit of Neulasta by stating that there is a statistically significant higher risk of febrile neutropenia when pegfilgrastim is administered through a prefilled syringe compared to an Onpro on-body injector. FDA determined the claims and presentations are not supported due to multiple limitations of the study’s design and analytic strategy. The promotional communication’s misleading claims and presentations could cause healthcare providers to conclude that pegfilgrastim delivered through the Onpro on-body injector is more effective than pegfilgrastim delivered through a prefilled syringe or that it is more effective than FDA-licensed biosimilar pegfilgrastim products, which are only delivered through a prefilled syringe.
Neulasta is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as pegfilgrastim or filgrastim. The prescribing information for Neulasta includes warnings and precautions such as splenic rupture, acute respiratory distress syndrome, serious allergic reactions, allergies to acrylics, use in patients with sickle cell disorders, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential for tumor growth stimulatory effects on malignant cells, myelodysplastic syndrome and acute myeloid leukemia in patients with breast and lung cancer in conjunction with chemotherapy and/or radiotherapy, potential device failures, and aortitis. The most common adverse reactions reported with use of Neulasta include bone pain and pain in extremity.
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