BioCentury
ARTICLE | Company News

FDA accepts BLA for Amgen's Humira biosimilar

January 26, 2016 2:14 AM UTC

Amgen Inc. (NASDAQ:AMGN) said FDA accepted for review a BLA for ABP 501, a biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV). Its action date under the Biosimilar User Fee Act (BsUFA) is Sept. 25.

Amgen said in November that it had submitted the BLA. The submission is Amgen's first of a biosimilar, and the company has said it believes ABP 501 is the first Humira biosimilar submitted to FDA (see BioCentury Extra, Nov. 25). ...