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AAC gives thumbs up to what could be first Humira biosimilar

By Mari Serebrov
Regulatory Editor

Wednesday, July 13, 2016

After struggling throughout the day with the concept of extrapolation and reliance on structural analytics rather than robust data from pivotal randomized, controlled trials for every indication, the FDA's Arthritis Advisory Committee (AAC) voted 26-0 Tuesday to support the licensure of Amgen Inc.'s Humira biosimilar.

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