Novartis Version of Enbrel Is Similar to Amgen’s, FDA Staff Says

  • Enbrel is Amgen’s top-selling drug at $5.36 billion in 2015
  • Novartis’s drug is a biosimilar, or near-copy, of Amgen’s

Novartis AG’s biosimilar version of the arthritis drug Enbrel, which the Swiss company is seeking to sell in the U.S. market, is comparable to the original made by Amgen Inc., U.S. regulators said.

Food and Drug Administration staff called the injection from Novartis “highly similar” to Enbrel to treat five chronic inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, according to a report released Monday. Agency advisers will meet Wednesday to consider recommending Novartis’s copy of Enbrel for market clearance. Enbrel was Amgen’s best-selling drug last year at $5.36 billion.

Biosimilars are near-copies of complex biologic drugs made from living organisms, as opposed to cheap versions of brand-name chemical treatments, called generics, that are typically easier to make. The FDA gained the authority to approve biosimilars from Congress in 2010 and has since cleared two: Novartis’s version of Amgen’s Neupogen cancer drug and a copy of Johnson & Johnson’s arthritis treatment Remicade that’s made by Pfizer Inc. and Celltrion Inc.

The advisory panel will consider another biosimilar, an Amgen version of AbbVie’s Humira, on Tuesday. Enbrel competes with top-selling Humira, made by AbbVie Inc.

Novartis studied the biosimilar, which the company calls GP2015, in plaque psoriasis and is seeking to extrapolate the data to other conditions that Enbrel treats. Even if the FDA approves the drug later this year, litigation between Novartis and Thousand Oaks, California-based Amgen may delay sales of the biosimilar.

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