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# PhRMA Wants ‘More Complete’ Interchangeability Guidance
- URL: https://www.fdaweb.com/phrma-wants-more-complete-interchangeability-guidance/
- Published: 2021-01-21T12:00:00.000Z
- Updated: 2026-09-14T16:43:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148500

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance, *Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development Under the BPCI Act*, should be revised to provide more complete guidance related to interchangeable products, including on: 

- consideration for developing presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products;
- labeling for interchangeable products;
- promotional labeling and advertising considerations for interchangeable products;
- quality considerations and further guidance on post-approval manufacturing changes; and
- the agency’s approach to reviewing 351(k) applications seeking an interchangeability determination that are **(1)** in review at the time a first interchangeable product is approved or **(2)** submitted during the pendency of an interchangeability exclusivity period.

The PhRMA comment [letter](https://downloads.regulations.gov/FDA-2011-D-0611-0086/attachment%5F1.pdf?ref=fdaweb.com) also asks that the final guidance revise the labeling statement on interchangeability to clarify that the product is interchangeable with the reference product and not with other biosimilar products.