UPDATE Amgen files for FDA approval of Humira biosimilar

26 November 2015

US biotech giant Amgen (Nasdaq: AMGN) yesterday announced the submission of a Biologics License Application (BLA) with the US Food and Drug Administration for ABP 501, a biosimilar candidate to AbbVie’s (NYSE: ABBV) mega-blockbuster inflammatory diseases drug Humira (adalimumab).

Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen's first BLA submission using the 351(k) biosimilar pathway, although several other companies are also developing biosimilars of Humira, which has annual sales of nearly $13 billion and still growing.

View: Amgen invites AbbVie to dance for Humira biosimilar

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