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# FDA Denies AbbVie Interchangeability Petition
- URL: https://www.fdaweb.com/fda-denies-abbvie-interchangeability-petition/
- Published: 2017-01-18T12:00:00.000Z
- Updated: 2026-09-14T22:00:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137745

FDA has denied an AbbVie 12/17/15 petition asking the agency to ensure that applicants seeking interchangeability determinations meet the “Safety Standards for Determining Interchangeability” in the Public Health Service Act for each condition of use for which the reference product is licensed, regardless of whether the applicant intends to label its product for each condition of use. The company also asked FDA to “clarify that the statutory standards for establishing interchangeability differ in both kind and scope from the standard for establishing biosimilarity.” Its final request was that the agency convene a hearing to obtain public input on the topic and then issue guidance or regulations to address the issue.

The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2015-P-4935-0007&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) notes that FDA published 1/17 a draft [guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf?ref=fdaweb.com) on considerations in demonstrating interchangeability with a reference product. “We encourage AbbVie to participate in FDA’s guidance development process by reviewing the guidance and submitting any comments to the public docket…,” it says. The agency says it intends to consider issues related to interchangeability in the context of the public document and does not intend to hold a public hearing or meeting on the draft guidance.