$SPPI Most recently, the FDA issued an untitled letter to Amgen over misbranding of Neulasta (pegfilgrastim) injection “resulting from a false or misleading promotional communication.” The company gives promotional materials that the FDA says make false or misleading claims about the benefit of Neulasta when dosed via the Onpro on-body injector compared to a prefilled syringe. Neulasta is the reference product for all biosimilar pegfilgrastim products approved by the FDA, and they’re only available as a prefilled syringe. The FDA stated, “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.
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