The Science of Biosimilars-Updating Interchangeability

Patrizia Cavazzoni; Sarah Yim

doi:10.1001/jama.2024.15225

The Science of Biosimilars-Updating Interchangeability

JAMA. 2024 Oct 15;332(15):1235-1236. doi: 10.1001/jama.2024.15225.

Authors

Patrizia Cavazzoni¹, Sarah Yim²

Affiliations

¹ Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland.
² Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland.

PMID: 39292484
DOI: 10.1001/jama.2024.15225

No abstract available

Plain language summary

This Viewpoint from the US Food and Drug Administration (FDA) summarizes a recent update to an FDA draft interchangeability guidance regarding the need for clinical switching studies to illustrate the FDA’s ongoing efforts to streamline the development of biosimilar medications that are in line with the latest science.

Publication types

Editorial

MeSH terms

Biosimilar Pharmaceuticals* / adverse effects
Biosimilar Pharmaceuticals* / standards
Clinical Studies as Topic / standards
Drug Approval / legislation & jurisprudence
Drug Substitution* / standards
Humans
Therapeutic Equivalency
United States
United States Food and Drug Administration*

Substances

Biosimilar Pharmaceuticals