Samsung Bioepis’ Etanercept Nod Prompts US Lawsuit
The FDA has approved Samsung Bioepis’ Eticovo as the second biosimilar competitor to Amgen’s blockbuster rheumatoid arthritis biologic Enbrel. Amgen immediately sued for patent infringement.
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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.
In the first part of an exclusive interview with Generics Bulletin, Samsung Bioepis CEO Christopher Hansung Ko sets out his views on the US biosimilar market.