FDA has denied AbbVie’s Citizen Petition on interchangeability.
Back in December 2015, AbbVie submitted a Citizen Petition to FDA requesting that the agency take certain actions regarding interchangeability standards for biosimilar applicants. Specifically, AbbVie requested that FDA:
(1) “ensure that applicants seeking interchangeability determinations meet the ‘Safety Standards for Determining Interchangeability’ set forth in Public Health Service Act (PHSA) section 351(k)(4) with respect to each condition of use for which the reference product is licensed, regardless of whether the applicant intends to label its product for every such condition of use”;
(2) “clarify that the statutory standards for establishing interchangeability differ in both kind and scope from the standard for establishing biosimilarity”; and
(3) “convene a Part 15 hearing to obtain public input on the topic… [and] then issue guidance or regulations that address this important public health issue.”
After considering comments from Sandoz and the Generic Pharmaceutical Association (GPhA), and issuing an interim response, FDA yesterday denied AbbVie’s Petition. FDA referenced its draft guidance on “Considerations in Demonstrating Interchangeability with a Reference Product,” published yesterday as well, and noted: “FDA intends to consider issues related to interchangeability in the context of the public docket opened for comment on the draft guidance.” In its denial letter, FDA “encourage[d] AbbVie to participate in FDA’s guidance development process by reviewing the guidance and submitting any comments to the public docket number FDA-2017-D-0154 on http://regulations.gov,” and stated “at this time, FDA does not intend to hold a public hearing or public meeting concerning the draft guidance,” as it “does not believe that such a hearing is necessary at this time.”