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# Draft Guide on Biosimilar Interchangeability
- URL: https://www.fdaweb.com/draft-guide-on-biosimilar-interchangeability/
- Published: 2017-01-18T12:00:00.000Z
- Updated: 2026-09-14T22:01:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137747

*Federal Register* Notice: FDA has made available a draft guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The document is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act. The guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009\. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-18/pdf/2017-01042.pdf?ref=fdaweb.com).