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# Reject AbbVie Biologic Criteria: Sandoz
- URL: https://www.fdaweb.com/reject-abbvie-biologic-criteria-sandoz/
- Published: 2016-03-24T12:00:00.000Z
- Updated: 2026-09-14T20:50:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135177

> Sandoz says that FDA should deny a 12/16/15 AbbVie petition asking the agency to require specific criteria before designating any product as an interchangeable biologic. AbbVie had called on FDA to require:  
> that interchangeability be established in 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; clarification that the statutory standards for interchangeability differ in both kind and scope from the standard for establishing biosimilarity; and convening a Part 15 hearing to obtain public input on the topic and only subsequently issue guidance or regulations addressing interchangeability.  
>  
> Sandoz’ [response](https://www.regulations.gov/contentStreamer?documentId=FDA-2015-P-4935-0003&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says that the rationale and data used as the basis of the petition are limited, misrepresented, and misleading; that the Biologics Price Competition and Innovation Act does not require the issuance of a guidance before FDA reviews and approves biosimilars and interchangeable biologics; and that a Part 15 hearing will not provide any new or additional knowledge on the topic that will not already be captured during the review and comment period following issuance of draft guidance on interchangeability.  
>  
> The response says that the AbbVie request should be denied because:  
> ample scientific evidence is available supporting the fact that the act of switching between a biosimilar and its corresponding reference product does not by itself raise concerns; the specter of increased immunogenicity due to the act of switching is purely hypothetical and is not supported by any existing scientific evidence; the concept of data extrapolation extends to the concept of interchangeability just as it applies to the initial assessment of biosimilarity; and it is unethical to conduct clinical studies in indications protected by patent or exclusivity reasons because study participants cannot expect to benefit by continued use of the drug after conclusion of the study.  
>  
> The Sandoz letter also asks FDA to clarify that **(1)** interchangeability does not represent a higher standard of safety or clinical effectiveness and thus interchangeability is a requirement for additional data and not a different standard; and **(2)** interchangeable biologics and biosimilars must be manufactured to the same quality levels as are applied to originator biologics.  
>  
> “We encourage the careful but ongoing process by which the agency is implementing the regulatory framework to allow safe and effective biosimilars to become available for U.S. patients,” the letter says. “We believe that the agency’s approach for the biosimilar development process for biosimilars and interchangeable biologics provides reassurance to prescribers, patients, and other stakeholders as to the quality of these products, will ongoing draft guidances scheduled for release in 2016.”