During oral arguments in Sandoz v Amgen, justices suggest FDA issue rule-making on whether biosimilar sponsors can give early notification of launches and need to follow all the steps in the patent dance. The agency has explicitly said it wants to be left out of it.
US Supreme Court justices seemed to disagree on whether a biosimilar sponsor must wait until FDA approval to provide notice it intends to market its product and whether the sponsor must hand over its application and manufacturing process information to the innovator.
During oral arguments April 26 in Sandoz Inc. v. Amgen Inc., Chief Justice John Roberts Jr. and Justices...
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European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
