Enbrel Battle Ends as Supreme Court Refuses to Hear Sandoz Appeal

Legal Battle_Compressed

After refusing to review a patent appeal, the U.S. Supreme Court dealt a devastating blow to the hopes of Novartis’ Sandoz business unit to market its biosimilar to Amgen’s Enbrel. The high court’s decision will prevent Sandoz from launching its biosimilar to Amgen’s blockbuster rheumatoid arthritis drug.

Enbrel’s patents do not expire until 2029. Sandoz, the generics and biosimilar unit of Swiss pharma giant Novartis, had appealed back-to-back losses in federal court attempting to discredit Enbrel’s patents to introduce Erelzi (etanercept-szzs) into the U.S. market. By refusing to take up the case, the Supreme Court upheld a 2019 U.S. District Court of New Jersey ruling that protected Enbrel’s patents. 

Last year Sandoz appealed that district court decision to the U.S. Court of Appeals, but that court also upheld the ruling. Now, the company will have to wait until Enbrel’s patents expire before Erelzi can be sold in the United States.

Karen Haruvi, president of Sandoz U.S. and Head of North America, expressed her disappointment in the Supreme Court’s decision not to review the case.

“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,” Haruvi said in a statement. 

Erelzi was approved by the U.S. Food and Drug Administration (FDA) in 2016 as a biosimilar for Enbrel, which was first approved in 1998. Even though Erelzi was approved three years ago, Sandoz has been unable to launch the drug due to the patents protecting the Amgen product. Enbrel was developed by Immunex, which was acquired by Amgen four years after the drug’s approval.

Last year, Enbrel generated approximately $5 billion for Amgen. It’s the Thousand Oaks, Calif. company’s top seller, accounting for about one-fifth of its $24.2 billion in product sales for 2020. 

Sandoz pointed to the benefits biosimilar drugs are expected to play in reducing healthcare costs in the United States. The company estimated that Erelzi could save the U.S. healthcare system approximately $1 billion per year. 

Biosimilars have been shown to have equivalent efficacy and comparable safety and immunogenicity, which means that physicians and patients can expect the same clinical outcome. Erelzi has been approved for use in Europe.

While Sandoz is disappointed in the outcome, Amgen is pleased. In a brief statement, the company said the Supreme Court’s decision not to review the case “finally bringing this dispute to an end.”

While Amgen was victorious in the Enbrel case, the company lost a legal battle against Sanofi and Regeneron earlier this year. Amgen had sought to uphold patent claims for its cholesterol drug Repatha against the rival drug Praluent, developed by Sanofi and Regeneron. However, in February, the U.S. Court of Appeals upheld a 2019 decision from a lower federal court that invalidated Amgen’s asserted patent claims for PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies.

Since the 2016 approval of both anti-cholesterol drugs, the companies had gone back and forth over the years fighting about the different patents. The February ruling appears to have settled the PCSK9 patent issue. 

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