On December 16, 2015, AbbVie submitted a Citizen Petition (link) (Docket No. FDA-2015-P-4935) to the FDA concerning the requirements for demonstrating interchangeability between a brand-name reference product and its biosimilar counterpart. In its Citizen Petition, AbbVie requested that the FDA take the following actions:
- FDA should “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” (emphasis in original);
- FDA should “clarify that the statutory standards for establishing interchangeability differ in both kind and scope from the standard for establishing biosimilarity”; and
- FDA should “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.”
In support of its first request, AbbVie points to public health interests, the structure and text of the BPCIA, the legislative history of the BPCIA, and the possibility that a biosimilar product could be changed after an interchangeability determination is made. AbbVie also cites to the BPCIA statute and raises public interest concerns in support of its second and third requests. Specifically, AbbVie argues that interchangeability “must be interpreted to require more than biosimilarity,”and that CDER has failed to issue its promised interchangeability guidance.
Stay tuned to the Big Molecule Watch for further developments on this issue.