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Amgen: No Proof Apotex Biosimilar Approval Looming

This article was originally published in Scrip

Executive Summary

There's no need to expedite Apotex Inc.'s appeal of a Florida district court's decision to impose a preliminary injunction (PI) on the firm preventing it from marketing its pegfilgrastim biosimilar for 180 days after FDA approval because there's no evidence the agency's verdict on the product is looming, Amgen Inc. said in court documents filed on Dec. 18.

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