FDA denies AbbVie petition for limiting biosimilar applications

FDA denied a Citizen's Petition from AbbVie Inc. (NASDAQ:ABBV) requesting that FDA decline to review any IND or other regulatory application for a biosimilar whose reference product's BLA was submitted for review before the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010. The petition specifically discussed biosimilars of Humira adalimumab, but would have applied to all reference products with BLAs submitted before March 23, 2010.

On Friday, FDA approved a BLA from Amgen Inc (NASDAQ:AMGN) for Amjevita adalimumab-atto. It is the first Humira biosimilar the agency approved (see BioCentury Extra, Sept. 23). ...