Biotech Values

[dewophile]

they cannot show pharmacokinetic properties

yes - i never disagreed with this point. whether this will make the difference between approvability or not is the question

after all you can't asses pk of lovenox in the traditional sense of measuring drug levels either - you need to indirectly check pk by measuring anti-Xa levels. so yes the big difference between lovenox and copaxone is there is no biomarker of activity that can be used for pk/pd - but i would also argue if approving generic lovenox requires simply showing one can achieve comparable inhibition of Xa/IIa activity then we will see multiple generics approved. However, if the FDA feels that Xa/IIa activity cannot fully descrive the activity of lovenox, and they approve an ANDA based on technology such as MNTA's, then i would argue having Xa/IIa as a biomarker is not the key to proving sameness - rather the technology and reverse engineering and showing similar batch to batch consistency of the final product mix is what is necessary, and having the luxury of a biomarker that gives some indication of activity of the final product then becomes merely supportive of the application