Am­gen los­es its bid to de­lay biosim­i­lars as SCO­TUS hands No­var­tis a vic­to­ry

Am­gen took their ar­gu­ment that its biosim­i­lar ri­vals should be forced to de­lay their 180-day mar­ket­ing no­tices un­til af­ter the FDA had made up its mind on the mar­ket­ing ap­pli­ca­tion all the way to the Supreme Court — and lost.

In a unan­i­mous rul­ing hand­ed down mid-day Mon­day, the Supreme Court de­cid­ed the key ques­tion by de­ter­min­ing that the law nev­er im­posed a two-tier tim­ing sys­tem for these no­tices. There­fore “the ap­pli­cant may pro­vide no­tice ei­ther be­fore or af­ter re­ceiv­ing FDA ap­proval.”

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