San­doz rais­es ques­tions with FDA draft guid­ance on sta­tis­ti­cal ap­proach­es for biosim­i­lars

Mar­tin Schi­estl, chief sci­ence of­fi­cer at No­var­tis’ San­doz, on Tues­day ex­plained how the FDA’s draft guid­ance on sta­tis­ti­cal ap­proach­es to eval­u­ate an­a­lyt­i­cal sim­i­lar­i­ty pos­es risks that could end up caus­ing true biosim­i­lars to be re­ject­ed ran­dom­ly.

Schi­estl told at­ten­dees of DIA’s biosim­i­lars con­fer­ence in Bethes­da, MD, that the prob­lem is re­lat­ed to equiv­a­lence test­ing, which FDA says in the draft, “is typ­i­cal­ly rec­om­mend­ed for qual­i­ty at­trib­ut­es with the high­est risk rank­ing and should gen­er­al­ly in­clude as­say(s) that eval­u­ate clin­i­cal­ly rel­e­vant mech­a­nism(s) of ac­tion of the prod­uct for each in­di­ca­tion for which ap­proval is sought.”

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