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No Comparison: FDA Draws Bright Line Between BLA, Biosimilar Pathways In Tbo-filgrastim Review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Teva’s tbo-filgrastim could have been the first review under FDA’s new biosimilars pathway, but Teva gambled that transplanting its successful European biosimilar G-CSF submission to the U.S. as a regular BLA had better odds. FDA used the review to make clear that it would be rigorous in distinguishing between 351(a) and 351(k) requirements.

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