Am­gen tees up a swift ap­proval for a fran­chise de­stroy­er aimed at Ab­b­Vie’s $14B drug Hu­mi­ra

The FDA wast­ed lit­tle time in com­ing to the point in their re­view of Am­gen’s ap­pli­ca­tion for ABP501, their new biosim­i­lar of Ab­b­Vie’s megablock­buster in­flam­ma­to­ry drug Hu­mi­ra: They got it right.

“In con­sid­er­ing the to­tal­i­ty of the ev­i­dence, the da­ta sub­mit­ted by Am­gen sup­port a demon­stra­tion that ABP 501 is high­ly sim­i­lar to US-li­censed Hu­mi­ra, notwith­stand­ing mi­nor dif­fer­ences in clin­i­cal­ly in­ac­tive com­po­nents, and sup­port a demon­stra­tion that there are no clin­i­cal­ly mean­ing­ful dif­fer­ences be­tween ABP 501 and US-li­censed Hu­mi­ra in terms of the safe­ty, pu­ri­ty, and po­ten­cy of the prod­uct to sup­port the demon­stra­tion that ABP 501 is biosim­i­lar to the US-li­censed Hu­mi­ra in the stud­ied in­di­ca­tions of RA and PsO,” the agency notes in their ex­ec­u­tive re­view.

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