ARTICLE | Company News

AbbVie, Amgen autoimmune, biosimilars news

October 3, 2016 7:00 AM UTC

FDA denied a Citizen's Petition from AbbVie 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. Last month, FDA approved a BLA from Amgen for Amjevita adalimumab-atto, a biosimilar of adalimumab, a human mAb against tumor necrosis factor (TNF) alpha. It is the first Humira biosimilar the agency approved.

AbbVie submitted the petition in 2010, claiming that the use of confidential information from reference products to review biosimilar applications violates trade secret protections of the Fifth Amendment. In its denial, FDA said reference product BLAs are available for public disclosure after approval and that AbbVie did not demonstrate "extraordinary circumstances" required to prevent disclosure of Humira's safety and efficacy data. ...