AAC gives thumbs up to what could be first Humira biosimilar
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.
Outside of the US
In the U.S. and Canada: +1-800-336-4474
Outside the U.S.: +44-203-684-1796
Hours: Monday - Friday, 8:00am - 6:00 pm EST