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# Comments Extended on Biosimilar Interchangeability Guidance
- URL: https://www.fdaweb.com/comments-extended-on-biosimilar-interchangeability-guidance/
- Published: 2017-03-15T12:00:00.000Z
- Updated: 2026-09-14T22:11:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138213

*Federal Register* Notice: FDA has extended the comment period for a 1/18 notice regarding a guidance on “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\. Comments now can be submitted by 5/19\. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-03-15/pdf/2017-05102.pdf?ref=fdaweb.com).