FDA's Worst Case Scenario: Supreme Court Might Defer To It On Biosimilars

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_V2_1200

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...

More from Legal & IP

More from Pink Sheet

Global Pharma Guidance Tracker - May 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 

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.

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 

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.