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...
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