FDA had to weigh whether and how differences in the presentations of Sandoz Inc.’s Zarxio (filgrastim-sndz) and its reference product, Amgen Inc.’s Neupogen (filgrastim), should be reflected in biosimilar labeling that was otherwise highly “generic-like” in approach.
Review documents show the agency advocated early on for the Neupogen label to serve as the model for Zarxio’s prescribing information and that adjustments had to be made to the biosimilar’s proposed labeling