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The Curious Case Of FDA, Zarxio’s Name And The USP Monograph

Executive Summary

U.S. Pharmacopeia says if Sandoz’s biosimilar meets the filgrastim monograph, it should carry the same nonproprietary name as Neupogen. FDA says it’s already determined the monograph does not apply, shedding some light on its approach to a temporary name for the first biosimilar.

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