Therapeutic innovation & regulatory science
Regulatory Requirements for Interchangeable Biosimilar Designation.
Praveen J Samy, Morgane C Mouslim, Charles L Bennett, Antonio J Trujillo
Published: 202510.1007/s43441-025-00897-6
Abstract
BACKGROUND: 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 interchan…
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