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FDA's Balancing Act: Early Hints at a Biosimilars

This article was originally published in RPM Report

Executive Summary

FDA opened the regulatory phase of the biosimilar debate by hearing from industry and other stakeholders about what an approval system should look like. But this information-gathering session wasn’t all one-sided: FDA officials offered some hints of what they are thinking too. And while there are some significant areas of disagreement—and outlier positions—there was also quite a bit of common ground.

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