- Date:
- September 19, 2025
- Time:
- 9:00 a.m. - 1:00 p.m. ET
Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), FDA will hold a scientific workshop on the development of interchangeable products to help identify future needs (e.g., guidance, research) on or before October 31, 2025. The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual public workshop on September 19, 2025, to meet the BsUFA III commitment. The meeting agenda includes presentations by representatives from the biosimilar industry on the future needs for the development of interchangeable products, discussions on specific interchangeable topics, and a panel discussion with industry.
Within 12 months following the public workshop, FDA will issue a draft strategy document for public comment that outlines the specific actions the agency will take to facilitate the development of interchangeable biosimilar biological products. FDA will consider public input and will publish a final strategy document within 9 months after the close of the public comment period on the draft strategy document.
The meeting agenda, federal register notice, additional materials, and any other updates will also be posted to this website as they become available.
Registration: https://www.eventbrite.com/e/future-needs-for-the-development-of-interchangeable-products-tickets-1481835763659
