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Public response derails biosimilar draft guidance
August 2018
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CHICAGO—The U.S. Food and Drug Administration (FDA) has withdrawn the draft guidance “Statistical Approaches to Evaluate Analytical Similarity” that was issued last September in light of public comments and a citizen petition filed by Sarfaraz K. Niazi, an adjunct professor at the University of Illinois and the founder of Pharmaceutical Scientist Inc. Niazi argued in favor of waiving bridging studies for qualified non-U.S. comparators and encouraging payers to reimburse only for biosimilars when prescribed for new patients, arguments with which the FDA commissioner agreed. Niazi also called attention to a number of errors in the proposed analytical similarity testing protocols and offered alternatives to help, among other things, streamline testing, make reference samples freely available and support testing in more homogenous populations.

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