Regulatory Requirements for Interchangeable Biosimilar Designation

Files

s43441025008976.pdf (667.45 KB)

Links to Files

https://link.springer.com/article/10.1007/s43441-025-00897-6

Permanent Link

https://doi.org/10.1007/s43441-025-00897-6
 http://hdl.handle.net/11603/41380

Collections

A. All Hilltop Institute (UMBC) Works
UMBC Staff Collection

Author/Creator

Author/Creator ORCID

https://orcid.org/0000-0002-6999-7588

Date

2025-11-16

Type of Work

journal articles
Text

Department

Program

Citation of Original Publication

Samy, Praveen J., Morgane C. Mouslim, Charles L. Bennett, and Antonio J. Trujillo. “Regulatory Requirements for Interchangeable Biosimilar Designation.” Therapeutic Innovation & Regulatory Science, November 16, 2025. https://doi.org/10.1007/s43441-025-00897-6.

Rights

Attribution 4.0 International

Subjects

Abstract

In 2019, the US Food and Drug Administration (FDA) finalized guidance for designating interchangeable biosimilars requiring pre-approval phase III clinical trials to evaluate safety when reference and biosimilar formulations are interchanged. In June 2024, Draft FDA Guidance on interchangeability relaxes FDA approval criteria focusing on analytic rather than clinical findings. This study examines US trends in interchangeable biosimilar approvals between 2019 and 2025, manufacturer strategies, and regulatory timelines.