25 July 2018 - In an extraordinary move, the FDA has withdrawn the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity,” after receiving public comments and one citizen petition.

But what makes the FDA about-face on biosimilar evaluation so monumental, is that it was the direct result of the citizen petition. Filed by one man: Dr. Sarfaraz Niazi, Adjunct Professor at the University of Illinois at Chicago and CEO of Pharmaceutical Scientist, Inc. When asked about his success in influencing the FDA, the man I once wrote about as the most interesting man revolutionising the health world, commented, “The idea of making biosimilars accessible has not worked out well to date primarily because of the complexity and redundancy in the regulatory pathway. 

After I pointed out the complexities and errors in the regulatory guidance and offered alternative approaches, the FDA Commissioner became motivated to make changes. This is the first time that the FDA has simply withdrawn one of its guidance.”

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