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

 
• By Derrick Gingery

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.

While not intended to be a statement of its potential regulatory or interchangeability status, FDA already has determined that the U.S. Pharmacopeia monograph for filgrastim does not apply to Sandoz Inc.’s recently approved biosimilar of the product, which may create difficulties for marketing or substitution efforts.

More immediately, the determination also may affect whether Zarxio (filgrastim-sndz) could eventually carry the same nonproprietary name as Amgen...

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