Supreme Court Rebuffs Novartis Appeal Over Amgen's Arthritis Drug Enbrel: Report

  • The Supreme Court turned away a petition from Sandoz seeking to challenge two Amgen Inc AMGN patents related to rheumatoid arthritis drug Enbrel, thus blocking Novartis AG’s NVS Sandoz from selling a biosimilar of the drug in the U.S. until 2029.
  • The justices turned away Novartis subsidiary Sandoz Inc’s appeal of a lower court decision that upheld the validity of the patents. The case involves the active ingredient in Enbrel.
  • Enbrel is Amgen’s top-selling drug, accounting for nearly $5 billion of the company’s $24.2 billion in product sales for 2020. Enbrel was launched in 1998 by Immunex Corp, which Amgen acquired in 2002.
  • Erelzi is available in Europe, where it helped contribute to a 20% increase in revenue sales for the Sandoz unit last year, Novartis said in its annual report.
  • Sandoz got regulatory approval in 2016 to sell biosimilar dubbed Erelzi, Immunex sued for patent infringement.
  • “Today’s decision means Erelzi, a more affordable biosimilar, will not be available to U.S. patients with autoimmune and inflammatory diseases until 2029,” Keren Haruvi, president of Sandoz US, said in a statement.
  • Amgen said it was pleased the Supreme Court denied Sandoz’s petition, “finally bringing this dispute to an end.”
  • Price Action: AMGN shares closed 0.40% higher at $252.38, and NVS shares closed 0.46% lower at $88.55 on Monday.
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