A US District Court Judge in New Jersey has upheld the validity of two of Amgen’s patents for its blockbuster arthritis treatment Enbrel, preventing the launch of a biosimilar developed by Novartis’ Sandoz division. So far, the US FDA has approved two Enbrel biosimilars, Sandoz’ Erelz in August 2016 and Samsung Bioepis’ Eticovo last April, but neither have launched commercially due to ongoing litigation. Enbrel was first approved by FDA in 1998. While the FDA has approved more than 20 biosimilars since approving its first in 2015, only about one-third have launched, in large part due to complicated intellectual property litigation that often takes years to resolve. Learn More