2016-07-13 18:30:37 UTC

FDA Advisory Panel Unanimously Recommends Approval of New Biosimilar for IBD

July 13, 2016

Amgen’s ABP 501, a biosimilar to AbbVie Inc.’s Humira (adalimumab), includes indications for inflammatory bowel disease.

On July 12, the FDA Arthritis Advisory Committee voted 26-0 in favor of recommending approval of the Humira biosimilar ABP 501 from Amgen. Amgen’s ABP 501 is a biosimilar to AbbVie Inc.’s Humira (adalimumab). Among several proposed indications for ABP 501, the biosimilar is proposed for use in inflammatory bowel disease patients to:

  • Reduce signs and symptoms and induce and maintain clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
  • Induce and sustain clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants, such as corticosteroids, azathioprine or 6-mercaptopurine.

Several gastroenterologists (both adult and pediatric) participated as temporary voting members of the committee, including Sarah Streett, MD, chair of the AGA Practice Management and Economics Committee. A staff representative from the AGA Center for Diagnostics and Therapeutics also attended the public hearing.

If approved by FDA, ABP 501 will be the second biosimilar with GI indications approved for the U.S. market. The first was Inflectra (infliximab-dyyb), which was approved by FDA in April 2016 for the treatment of IBD.

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