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# BsUFA 3 Changes Described
- URL: https://www.fdaweb.com/bsufa-3-changes-described/
- Published: 2023-01-17T12:00:00.000Z
- Updated: 2026-09-14T18:12:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153548

CDER Office of Therapeutic Biologics and Biosimilars director **Sarah Yim** says the Biosimilar User Fee Amendments 3 commitment letter includes goals for FDA to create foundational guidances for interchangeable biosimilar biological product development. Writing in an online *CDER Conversation* [post](https://www.fda.gov/drugs/news-events-human-drugs/cder-conversation-biosimilar-user-fee-amendments-latest-implementation-bsufa-iii?ref=fdaweb.com), Yim says the intent is to develop guidances that cover presentations, container closure systems and device constituent parts, labeling for interchangeable products, promotional labeling and advertising considerations, alternative tools to assess manufacturing facilities, and post-approval manufacturing changes.

“We also plan to advance the development of biosimilar biological-device combination products by introducing procedures and timelines for FDA review of use-related risk analysis and human factors validation study protocols,” she writes.

In the same post, Office of Biotechnology Products director **Steven Kozlowski** says a new Biosimilar Regulatory Science Program is supporting Center efforts to enhance biosimilar product development and regulatory science. He says the program is focused on **(1)** improving the efficiency of biosimilar product development and **(2)** advancing the development of interchangeable products. FDA recently awarded grants for five projects to help meet the goals, Kozlowski writes.