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Apotex Seeks To Dance Quick Step In Biosimilars Appeal

This article was originally published in Scrip

Executive Summary

Apotex Inc. revealed in court documents late on Dec. 14 that it anticipates the FDA to make a decision on the company's 351(k) application for its pegfilgrastim biosimilar "within the next several months" – providing some insight into the status of the product, whose verdict was due nearly two months ago and for which the firm has kept a tight lip.




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