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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