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Novartis/Sandoz biosimilar 1st to win FDA panel backing

This article was originally published in Scrip

Executive Summary

A biosimilar from Novartis and its Sandoz unit on 7 January was wholeheartedly embraced by the FDA's Oncologic Drugs Advisory Committee (ODAC), which voted 14-0 the totality of evidence supported licensing for all five indications sought by the firms for their version of Amgen's Neupogen (filgrastim).



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