Improper Orange Book listings harm competition, FTC says in amicus brief to antitrust suit

The FTC on Mon­day filed an am­i­cus brief in My­lan Phar­ma­ceu­ti­cals’ an­titrust law­suit al­leg­ing that Sanofi abused the FDA’s Or­ange Book to de­lay and block My­lan’s gener­ic in­sulin from com­pet­ing with Sanofi.

In the suit, filed in May in the US Dis­trict Court for the West­ern Dis­trict of Penn­syl­va­nia, My­lan (now known as Vi­a­tris) al­leges that Sanofi used the Or­ange Book process to block the biosim­i­lar to in­sulin known as Sem­glee from com­pet­ing with Sanofi’s brand­ed prod­uct.

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