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BioPharmaceutical United States Approvals

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

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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