Nine More Years? Sandoz Loses Again On Enbrel Biosimilar
Sandoz Has Held FDA Approval For Its Erelzi Version Since 2016
Sandoz has failed to overturn on appeal an invalidity ruling for two patents covering Enbrel in the US, barring a path to market for its Erelzi biosimilar, potentially until patent expiry in 2029.
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Samsung Bioepis’ etanercept biosimilar, freely available in Europe, will not be sold in the US until patent expiry in 2029 following action by a US district court.
Sandoz’ arguments urging the US Supreme Court to review patent litigation around Amgen’s Enbrel have fallen on deaf ears, blocking a route to market for biosimilar etanercept until 2029 in the US.
Amgen has hit back at Sandoz’ petition for a writ of certiorari against a US Court of Appeals for the Federal Circuit decision that leaves the biosimilar sponsor unable to market its Enbrel biosimilar more than three decades after the biologic was first launched.