Sowing confusion in the field: the interchangeable use of biosimilar terminology

Abstract

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure pathway in the United States that allows for the development and approval of biologic products shown to be biosimilar to or interchangeable with a US Food and Drug Administration (FDA)-licensed reference product. FDA released the draft guidance for industry on Demonstrating Interchangeability with a Reference Product (hereafter referred to as the Draft Interchangeability Guidance) in January 2017. Despite FDA’s efforts, there continues to be a great deal of confusion and misinformation surrounding the topic of interchangeability. Here we discuss interchangeability, as well as substitution of biological products, with a focus on the US. Additionally, the separate topic of physician-mediated switching is covered and distinguished from interchangeability and substitution.

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Declaration of funding

The contents of the paper and the opinions expressed within are those of the authors, and it was the decision of the authors to submit the manuscript for publication.

Declaration of financial/other relationships

All authors declare being employees and stockholders of Pfizer. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

None reported.