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 …

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