The Supreme Court declined to review a petition filed by Novartis' Sandoz unit that challenged two of Amgen's patents on its blockbuster rheumatoid arthritis drug, Enbrel, meaning there won't be a biosimilar version of the drug in the U.S. until 2029, Bloomberg reported May 17.
Sandoz received regulatory approval in 2016 to sell a biosimilar version of Enbrel it calls Erelzi, but the two patents are blocking it from putting its version of the drug on the market. Sandoz claimed in its petition that an appeals court should not have upheld the patents that prevent it from entering the market.
Enbrel made Amgen $5 billion in sales last year, 20 percent of its revenue, according to Bloomberg. The drug has been on the market since 1998, and the Supreme Court's decision not to review the petition gives Amgen a total of 31 years of market exclusivity on the drug.
Enbrel is approved to treat rheumatoid arthritis and plaque psoriasis. It competes with other brand-name drugs including AbbVie's Humira and Johnson & Johnson's Remicade and Stelara, Bloomberg reported.
Sandoz has claimed a biosimilar version of Enbrel could have saved the U.S. healthcare system $1 billion per year, Bloomberg reported.
"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 to Bloomberg. "We remain committed to providing important treatment options for patients affected by these diseases."
Amgen said in a statement to Bloomberg that it is pleased with the Supreme Court's decision to deny Sandoz's petition, "finally bringing this dispute to an end."
"As the trial court and appeals court decisions make plain, upon both the facts and the law, these patents are valid and protect Enbrel until their expiration," the drugmaker said.
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