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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