An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on July 12, 2016.
Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s GP2015 biosimilar of Amgen’s Enbrel (etanercept) on July 13, 2016.
Our previous coverage noted that the FDA made a preliminary determination that ABP501 is “highly similar” to Humira.
Continue following Big Molecule Watch for more updates.