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Biosimilars in 2014: An Interview With FDA New Drugs Head John Jenkins

This article was originally published in RPM Report

Executive Summary

In addition to John Jenkins’ role as FDA’s top new drug review manager, he serves as head of the Biosimilars Review Committee—the internal panel tasked with grappling with actual application review issues for the abbreviated 351(k) program. The RPM Report spoke with Jenkins during the FDA/CMS Summit for Biopharmaceutical Executives in December. Here is an edited transcript of the conversation.

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