Big Molecule Watch
October 21, 2015

AbbVie Citizen Petition Update

As we reported in an earlier post, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants. Since then, several entities have submitted comments regarding AbbVie’s petition—some in support and others adamantly opposing—and AbbVie has supplemented its original petition. We’ve summarized those submissions in the table at the bottom of this post.

Under the Food and Drug Administration Safety and Innovation Act, FDA has 150 days to respond to AbbVie’s petition, and that period cannot be extended for any reason, including based on the submission of comments or supplemental information. Based on AbbVie’s submission date of June 2, 2015, we expect FDA to issue its response around the end of next week. Check back here soon for updates.

Filer  Submission Type  Submission Date  Position re: AbbVie’s Citizen Petition 
Alliance for Safe Biologic Medicines Comment July 16, 2015 “It is our hope that our study results and their implications will serve to assist the FDA in its difficult task of approving future biosimilar medications as well as in developing your policy on product labeling, which I understand is scheduled to be issued later this year.”
Amgen Comment July 20, 2015 “Amgen supports the policy approach that AbbVie advocates in its Citizen Petition.  We thus respectfully urge FDA to promulgate a labeling policy that begins with
transparency, supports consumer confidence, and facilitates appropriate use.”
 Momenta Comment July 29, 2015 “The AbbVie Citizen Petition seeks to promote policy that would undermine such innovation and we urge that it be denied.”
 AbbVie Supplement August 10, 2015 “This supplement provides additional relevant information and addresses events that arose after the Petition was filed.”
 Sandoz Comment August 19, 2015 “Sandoz, a Novartis company, respectfully submits this response to the AbbVie Citizen petition to recommend the Food and Drug Administration reject the CP in its entirety.”
 Genentech Comment August 27, 2015 “Genentech generally supports the AbbVie Petition and recommends that FDA adopt a transparent labeling approach for biosimilars that reflects their unique scientific characteristics and statutory approval pathway.”