US Supreme Court Denies Sandoz Petition to Review Biosimilar Erelzi® Case

Sandoz has announced that the US Supreme Court has denied its petition to review the Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi® (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 US patients with autoimmune and inflammatory diseases until 2029; nonetheless we remain committed to providing important treatment options for patients affected by these diseases.”

With the trend towards increased spending on specialty medicines only expected to grow,1 biosimilars play an important role in enabling more patients to access biologic medicines and may offer significant savings for patients, helping to alleviate the overburdened healthcare system.2,3 Estimates suggest that a biosimilar etanercept could have saved the US healthcare system around USD one billion per year.4

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