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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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.
Markets are re-assessing Amgen’s long-term value after a US judge upheld two patents relating to Amgen's blockbuster rheumatoid arthritis drug Enbrel, denying a challenge by Novartis and allowing investors to focus now on the pharma’s promising pipeline.