Regulatory Requirements for Interchangeable Biosimilar Designation

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dc.contributor.authorSamy, Praveen J.
dc.contributor.authorMouslim, Morgane
dc.contributor.authorBennett, Charles L.
dc.contributor.authorTrujillo, Antonio J.
dc.date.accessioned2026-01-06T20:51:51Z
dc.date.issued2025-11-16
dc.description.abstractIn 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.
dc.description.sponsorshipThis work was supported by Arnold Ventures.
dc.description.urihttps://link.springer.com/article/10.1007/s43441-025-00897-6
dc.format.extent3 pages
dc.genrejournal articles
dc.identifierdoi:10.13016/m2dvaw-robe
dc.identifier.citationSamy, 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.
dc.identifier.urihttps://doi.org/10.1007/s43441-025-00897-6
dc.identifier.urihttp://hdl.handle.net/11603/41380
dc.language.isoen
dc.publisherSpringer Nature
dc.relation.isAvailableAtThe University of Maryland, Baltimore County (UMBC)
dc.relation.ispartofA. All Hilltop Institute (UMBC) Works
dc.relation.ispartofUMBC Staff Collection
dc.rightsAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.titleRegulatory Requirements for Interchangeable Biosimilar Designation
dc.typeText
dcterms.creatorhttps://orcid.org/0000-0002-6999-7588

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