Biosimilar Approval: Better, Stronger, Faster

By Sara W. Koblitz — We have the technology. It will definitely cost more than six million dollars, and there are questions about whether it will be better than it was before.  But Dr. Sarfaraz Niazi thinks he can rebuild the biosimilar approval process to make it more efficient. In an interesting Citizen Petition posted last week on regulations.gov, Dr. Niazi provides recommendations to FDA to revamp and expedite the biosimilar approval process. Dr. Niazi, the Forbes-proclaimed “most interesting man revolutionizing the health world” and the man who coined the term “biosimilars,” a professor at the University of Illinois at Chicago and author of multiple bioequivalence textbooks.  In his May 11, 2018 Citizen Petition, he provides a myriad of suggestions for FDA to expedite the biosimilar approval process. A freestanding petition (i.e. not submitted as a comment on an FDA proposal or a response to a request for information) that was…

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