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

 
• By Donna Young

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.

Amgen Inc. has been eyeing the $14bn in cash rival AbbVie Inc. has been hauling in with its blockbuster Humira (adalimumab) – in fact the world's top-selling drug – and the FDA doesn't appear it will stand in the way.

Indeed, in briefing documents released ahead of a July 12 meeting of the FDA's Arthritis Advisory Committee, regulators all but...

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