The U.S. Supreme Court denied taking up Sandoz’s petition for it to review earlier decisions that had favoured Amgen in the long-running patent litigation. Biosimilar Etanercept is now barred until 2029 in the US.
In 2019, New Jersey federal district court ruled in favor of the Amgen, though Sandoz appealed, the U.S. Court of Appeals for the Federal District upheld the lower court’s decision.
As per Thomson, Enbrel is indicated for moderate-to-severe active rheumatoid arthritis treatment. It accounts for approximately $5bn of Amgen’s $24.2bn generated in product sales last year. According to Sandoz an Enbrel biosimilar could have saved the US healthcare system about $1 billion per year.
The decision not only dampens Sandoz’ hopes on Enbrel it also disappoints the generics pursuing the biosimilar strategy.