Sandoz Says US Supreme Court Denies Its Petition To Review Biosimilar Erelzi Case

(RTTNews) - Sandoz, a Novartis (NVS) unit, said Monday that the US Supreme Court has denied its petition to review the Federal Circuit's July 2020 decision concerning the Sandoz biosimilar Erelzi or etanercept-szzs for reference medicine Enbrel or etanercept. The Federal Circuit previously ruled against Sandoz in a divided decision upholding Amgen's patents.

Sandoz said it is disappointed the Supreme Court decided not to review its case. The decision means Erelzi, a more affordable biosimilar, will not be available to US patients with autoimmune and inflammatory diseases until 2029. However, the company remains committed to providing important treatment options for patients affected by these diseases.

Sandoz noted that it was the first company to receive approval from the US Food and Drug Administration 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 the medicine in the US due to the patent litigation.