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Biosimilars: Does FDA Caution Make Advisory Committee A Rubber Stamp?

 
• By Sue Sutter

Like biosimilar candidates Zarxio and Inflectra before it, Amgen's ABP 501 enters its advisory committee review with FDA's full-throated endorsement.

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FDA's decision to convene an advisory committee for early biosimilar applications may be viewed as a strong predictor of approval if the experience of Amgen Inc.'s ABP 501 mirrors that of its two predecessors to reach this stage.

Agency briefing documents released ahead of the Arthritis Advisory Committee's July 12 meeting on ABP 501, a proposed biosimilar to AbbVie Inc.'s Humira (adalimumab), suggest little reason to believe that the product will not follow in the footsteps of Sandoz Inc

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