Amgen's first biosimilar Biologics License Application for ABP 501 submitted to FDA
Amgen announced the submission of a BLA with the FDA for ABP 501, a biosimilar candidate to Humira® (adalimumab). Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen's first BLA submission using the 351(k) biosimilar pathway. November 26, 2015