FDA Releases a Final Q&A Guidance for Industry on Biosimilar Development and the BPCI Act

This guidance finalizes Q&As on topics of importance to biosimilar and interchangeable biosimilar product developers, such as the submission

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Releases a Final Q&A Guidance for Industry on Biosimilar Development and the BPCI Act   FDA is issuing 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and Answers on Biosimilar Development and the BPCI Act" (December 2018), by finalizing Q&As that were described in the draft guidance "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)" (December 2018).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.   FDA is also releasing the draft guidance: "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)." This draft guidance retains Q.I.12 from the previous version of the draft guidance, and this draft Q&A addresses how an applicant can demonstrate that its proposed injectable biosimilar product or proposed injectable interchangeable biosimilar product has the same "strength" as the reference product. These Q&A guidance documents are part of a series of guidance documents that FDA has developed to facilitate development of biosimilar and interchangeable biosimilar products and they are another step we're taking to provide increased regulatory certainty and predictability for stakeholders. Increased competition from biosimilar and interchangeable biosimilar products can help bring down the costs of biological products, improving patient access to important therapies. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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