Victory Swings Back To Gilenya Generics With Latest US Supreme Court Order
Topsy-Turvy Case Saw ‘Imminent’ Gilenya ANDA Launches Halted By Supreme Court
Novartis, which reportedly generates $3.8m per day in US Gilenya sales, is once again facing up to the prospect of imminent generic competition to its blockbuster treatment for relapsing-remitting multiple sclerosis, following the latest order by the US Supreme Court.
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In a dramatic twist, Gilenya ANDA sponsors are now unable to launch their generic products in the US after the US Supreme Court intervened in favor of originator Novartis, superseding the US Federal Circuit.
Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.
ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.