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Courts, Not FDA Panel, Likely Bigger Hurdle For Amgen's Humira Biosimilar

Executive Summary

Amgen Inc. appears to have a smooth path to FDA approval of its biosimilar of AbbVie Inc.'s tumor necrosis factor Humira (adalimumab) based on documents released ahead of a July 12 advisory committee meeting. But don't expect AbbVie to just sit back and take it.

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