Issue Date: March 9, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Biosimilars
Status: Draft
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry
This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar and interchangeable biosimilar products, as well as describe FDA’s interpretation of certain statutory requirements related to the abbreviated licensure pathway for biological products added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance revises and replaces the draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)” issued September 17, 2021 to provide certain revisions to Q&As I.8, I.10, and I.19, which have been withdrawn from the final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act” issued September 20, 2021.
Download the Guidance Document
