FDA Announces Availability of Draft Guidance for Biosimilar Product Development
March 11, 2026
March 11, 2026
WASHINGTON, March 11 (TNSFR) (TNSrep) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced the availability of a guidance entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)". This document is designed to assist applicants in the development of proposed biosimilar and interchangeable biological products.
The guidance (https://www.fda.gov/media/119278/download) provides the FDA's int . . .
The guidance (https://www.fda.gov/media/119278/download) provides the FDA's int . . .