FDA Panel Votes to Approve First U.S. Biosimilar Drug

Strategic Insights -

A Food and Drug Administration advisory panel has recommended approval of a generic version of Neupogen, a biotech drug used to boost white blood cells in cancer patients. The panel voted 14 to 0 in favor of the recommendation, which could lead to the first U.S.-approved "biosimilar" in a potentially booming market. The decision was influenced by the 2010 health care law, which called for speeding up approval of generic biotech drugs to lower costs.

Key Takeaways:

  • The FDA panel voted 14 to 0 to recommend approval of a generic version of Neupogen, a $1.4 billion drug produced by Amgen Inc.
  • The generic version, known as EP2006, is a biosimilar of Neupogen, which is used to boost white blood cells in cancer patients.
  • The decision was influenced by the 2010 health care law, which called for speeding up approval of generic biotech drugs to lower costs, with potential savings estimated at $250 million by 2024.
  • The FDA is currently reviewing at least two applications for other biosimilars, with as many as 5,000 in development.
  • The generic product, designed by Novartis' Sandoz unit, has already been approved in over 60 countries and has logged more than 7.5 million "patient days" since its initial approval in Europe in 2009.
  • The panel had to determine whether EP2006 was "highly similar" to Neupogen and whether there were meaningful clinical differences, with some panelists expressing concern about discrepancies in datasets.
  • The FDA reviewers noted an issue of a "lower protein count" with the Novartis product, but added that "this issue may be resolved by manufacturing and control strategies."

Statistics:

  • The $1.4 billion drug Amgen Inc.'s Neupogen is used by cancer patients to boost white blood cells.
  • Potential savings from the approval of the generic version are estimated at $250 million by 2024.
  • Over 7.5 million "patient days" have been logged since the generic product was initially approved in Europe in 2009.
  • The FDA is currently reviewing at least two applications for other biosimars.
  • As many as 5,000 biosimars are in development.
  • The generic product is the first biotech generic drug on the U.S. market.

Sources:

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