FDA’s Interim Response to AbbVie’s Citizen Petition

As we’ve previously reported, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants, and several other entities subsequently submitted comments on AbbVie’s petition.  On December 1, 2015, FDA issued an interim response to AbbVie’s petition indicating that “FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials.”  FDA says it will respond to the petition as soon as it reaches a decision, but provides no indication as to when that will be.

Stay tuned to the Big Molecule Watch for further developments.