US Supreme Court Denies Sandoz Biosimilar Etanercept Petition

BioPharm International Editors

The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.

On May 17, 2021, Sandoz, a Novartis company, announced that the US Supreme Court has denied its petition to review a July 2020 decision passed by the Federal Circuit concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept), an Amgen innovator biologic for treating autoimmune and inflammatory diseases. The Federal Circuit previously ruled against Sandoz in a divided decision upholding Amgen’s patents.

The decision not to review the Federal Circuit’s July 2020 ruling continues to prevent Sandoz from launching Erelzi in the United States. The company will be required to wait until 2029 to launch its biosimilar product, Sandoz said in a company press release. Erelzi was approved by FDA in August 2016.

Enbrel is Amgen’s top-selling drug, with nearly $5 billion in global sales in 2020, accounting for 21% of the company’s total global product sales in that year (1).

“We are disappointed the Supreme Court decided not to review our case,” said Keren Haruvi, president of Sandoz US and head of North America, in the company press release. “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.”

Erelzi is a registered trademark of Novartis.

Source: Novartis

Reference

1. Amgen, “Chairman and CEO Letter and Amgen Inc. 2020 Annual Report,” www.amgen.com, March 30, 2021.