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# Brookings Economist Backs FDA Biosimilar Draft Guide
- URL: https://www.fdaweb.com/brookings-economist-backs-fda-biosimilar-draft-guide/
- Published: 2026-05-07T12:00:00.000Z
- Updated: 2026-09-14T13:38:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161111

A Brookings Institution Center on Health Policy economist says he generally supports the approach FDA took in its draft guidance on New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act. The comment [letter](https://www.brookings.edu/wp-content/uploads/2026/05/Biosimilar-Guidance-Comment-RConrad-May-5-2026%5F.pdf?ref=fdaweb.com) commends the agency for changes that clarify the use of non-U.S.-licensed comparator products.

“By allowing sponsors to meet FDA’s requirements through more efficient means without lowering evidentiary standards, these updates should help reduce development costs and shorten timelines,” the letter says.

The comment gives detailed perspectives on:

- lowering development costs associated with using non-U.S.-licensed comparators;
- calibrating reserve sample rules to real-world testing frequency;
- commercial dynamics, not regulatory costs, often deter biosimilar entry; and
- clarifying the guidance while acknowledging the limits of FDA’s reach.