FDA rolls out ex­pec­ta­tions for a loom­ing reg­u­la­to­ry shift for in­sulin and oth­er bi­o­log­ics

Cer­tain bi­o­log­ics will be re­moved from the FDA’s Or­ange Book on 23 March 2020 and in­clud­ed in the Pur­ple Book, and all sub­se­quent fol­low-on ap­pli­cants will not be able to re­ly up­on these new drug ap­pli­ca­tions for ap­proval but will have to win ap­proval as biosim­i­lars un­der new pro­posed rules on biosim­i­lar de­vel­op­ment.

The agency on Tues­day re­leased two new draft Q&A guid­ance doc­u­ments on biosim­i­lar de­vel­op­ment and the “deemed to be a li­cense” pro­vi­sion of the Bi­o­log­ics Price Com­pe­ti­tion and In­no­va­tion Act of 2009 (BP­CIA), as well as two fi­nal guid­ance doc­u­ments on the same top­ics and one pro­posed rule amend­ing the de­f­i­n­i­tion of a bi­o­log­i­cal prod­uct.

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