Supreme Court denies Sandoz petition to review biosimilar Enbrel case

Sandoz on Monday announced that the U.S. Supreme Court has denied its petition to review the Federal Circuit’s July 2020 decision concerning Sandoz biosimilar Erelz (etanercept-szzs) for reference medicine Enbrel (etanercept). The Federal Circuit previously ruled against Sandoz in a divided decision upholding Amgen’s patents.

“We are disappointed the Supreme Court decided not to review our case,” said Keren Haruvi, president of Sandoz US and Head of North America. “Today’s decision means Erelzi, a more affordable biosimilar, will not be available to U.S. patients with autoimmune and inflammatory diseases until 2029; nonetheless we remain committed to providing important treatment options for patients affected by these diseases.”

Sandoz was the first company to receive approval from the Food and Drug Administration for a biosimilar etanercept and the first to launch a biosimilar medicine in the United States. Erelzi has been approved in the United States for more than four years, since August 2016, however Sandoz has been unable to launch this medicine in the United States due to the patent litigation.