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# Guide on Demonstrating Biosimilar Interchangeability
- URL: https://www.fdaweb.com/guide-on-demonstrating-biosimilar-interchangeability/
- Published: 2019-05-14T12:00:00.000Z
- Updated: 2026-09-15T01:26:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144098

*Federal Register* notice: FDA has made available a final guidance entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The document focuses on therapeutic protein products and gives an overview of important scientific considerations in demonstrating interchangeability of a proposed therapeutic protein product with a reference product. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-14/pdf/2019-10001.pdf?ref=fdaweb.com).