Illinois college of pharmacy petitions FDA to remove clinical requirements for biosimilars
The University of Illinois Chicago’s College of Pharmacy last week petitioned the FDA to remove clinical efficacy testing for all new biosimilars — and not just to lessen the costs of developing these large molecules but because of “ethical and hazardous concerns.”
The university says it’s assisting the US Senate in advancing a bipartisan bill that would remove the interchangeable status from the law that created the biosimilars pathway “since it creates two classes, leading to a lack of confidence in biosimilars, leaving the testing options, in most cases, to larger companies developing biosimilars.”
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