New FDA Guidance for industry on biosimilar development

The US Food and Drug Administration on Friday is issued a final guidance with questions and answers (Q&As) related to development and licensure of biosimilar and interchangeable biosimilar products: “ Questions and Answers on Biosimilar Development and the BPCI Act.”

This guidance revises the final guidance “Questions and Answers on Biosimilar Development and the BPCI Act” (December 2018), by finalizing Q&As that were described in the draft guidance “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)” (December 2018). The objective of this guidance is to provide rapid, development-related guidance to biosimilar and interchangeable biosimilar sponsors and other stakeholders on discrete issues. FDA regularly updates the guidance with Q&As as they are identified and finalized.

This guidance finalizes Q&As on topics of importance to biosimilar and interchangeable biosimilar product developers, such as the submission of a supplement to an approved application for a biosimilar, including the nature and type of information a sponsor should provide to support a post-approval manufacturing change for a licensed biosimilar or interchangeable biosimilar.