FDA ex­perts unan­i­mous­ly en­dorse Am­gen’s biosim­i­lar of Ab­b­Vie’s $14B fran­chise drug

An FDA pan­el of­fered a clear en­dorse­ment of Am­gen’s fran­chise-bust­ing biosim­i­lar of Ab­b­Vie’s $14 bil­lion bi­o­log­ic Hu­mi­ra.

The vote was unan­i­mous in fa­vor of an ap­proval on a broad slate of in­di­ca­tions.

“I thought the vot­ing was easy,” not­ed pan­elist Steve Sol­ga, the chief of gas­troen­terol­o­gy at St. Luke’s Uni­ver­si­ty Hos­pi­tal, echo­ing the pan­el’s con­sen­sus that there could be lit­tle to ar­gue with the FDA, par­tic­u­lar­ly as more thorny is­sues were not cov­ered in the dis­cus­sion.

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