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Biosimilar Labeling Dissected: Sandoz’s Zarxio Uses Amgen’s Neupogen Text

Executive Summary

FDA took same approach with biosimilar labeling that it takes with generic drug and 505(b)(2) products, Office of New Drugs Director Jenkins says. Labeling for filgrastim-sndz contains clinical data from Neupogen label, but not Sandoz’ clinical studies.

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