> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Comments on Therapeutic Protein Guidance
- URL: https://www.fdaweb.com/comments-on-therapeutic-protein-guidance/
- Published: 2020-11-11T12:00:00.000Z
- Updated: 2026-09-14T16:36:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148062

The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on a drug-drug interaction assessment for therapeutic proteins provides helpful information to sponsors regarding assessing such interactions. “The opportunity for sponsors to consider the specifics of their particular therapeutic proteins in the context of specific indications and concomitant medications and propose a fit-for-purpose development strategy in consultation with the agency is appreciated,” the comment [letter](https://www.regulations.gov/document?D=FDA-2020-D-1480-0014&ref=fdaweb.com) says.

BIO suggests that the guidance include a discussion on the potential of generalizing information between ADCs (antibody-drug conjugates) that share the same payload. “It would be helpful to understand, from FDA’s perspective, under what conditions it would be possible to apply information from a drug-drug interaction study conducted using an ADC to another ADC that had the same payload,” BIO says. The association also gives specific line-by-line comments.

A Pfizer comment [letter](https://www.regulations.gov/document?D=FDA-2020-D-1480-0015&ref=fdaweb.com) quotes and expands upon the BIO general comments and gives specific comments.