Some time ago, the US Supreme Court refused to accept Sandoz and Amgen's patent dispute over its anti-inflammatory blockbuster Enbrel. A few days ago, Amgen repelled a second potential competitor and ensured that the launch of Samsung's Enbrel biosimilar drug was postponed to 2029.

According to the latest verdict, the U.S. District Court of New Jersey supports the claims of Amgen, Roche and Immunex, requiring Samsung Bioepis’ Enbrel biosimilar Eticovo not to enter the U.S. market before 2029. According to documents filed last month, the US court held that if Samsung tried to sell its imitations before the patent expires in 2029, the company would be suspected of infringing on two Enbrel patents.

The update of this court decision marks the second patent setback for Enbrel biosimilars this year. In May of this year, the US Supreme Court rejected Sandoz's request to review its biosimilar drug Erelzi. As with Samsung, the court decision at the time also postponed the launch of Sandoz's biosimilars to 2029.

According to the latest judgment, Samsung Bioepis will not be able to manufacture, sell or import Enbrel biosimilar drugs in the United States before 2029. In addition, the court also ordered Samsung to immediately destroy any remaining Enbrel biosimilars that have been imported into the United States. Etanercept is the general name of Enbrel, which is a tumor necrosis factor inhibitor used to treat rheumatoid arthritis, ankylosing spondylitis, etc. Enbrel was first approved in 1998, which also means that when Samsung and Sandoz's biosimilar drugs are on the market, it will enjoy a full 31 years of US market exclusivity. Sandoz said that Enbrel biosimilars could save the United States about $1 billion annually.

Enbrel is the world's first TNF inhibitor used in rheumatoid arthritis and ankylosing spondylitis. The drug was approved for marketing in China in 2010. Evaluate Pharma predicted last year that Enbrel may become one of the best-selling drugs of all time. It is estimated that by 2024, Enbrel's lifetime sales will reach $139.8 billion. This will make it rank third in the blockbuster legend list, second only to AbbVie's Humira and Pfizer's Lipitor.

In terms of patents for other therapies, Amgen also recently requested the US Supreme Court to intervene and review its long-standing PCSK9 patent dispute with Sanofi and Regeneron. Specifically, Amgen hopes that the Federal Circuit will revoke the previously declared invalid decision of two patents for the cholesterol drug Repatha.