FDA Advisory Panels Considering Approvals of Two Biosimilars This Week

Biosimilar News  •  BPCIA and Related U.S. Statutes  •  U.S. FDA News

An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on Tuesday.

Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s GP2015 biosimilar of Amgen’s  Enbrel (etanercept) today.

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.

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