FDA Issues Revised Final Guidance on Biosimilar Development and the BPCI Act

TOP - October 2021 Vol 14, No 6 | Biosimilars - FDA Updates, Biosimilars

On September 20, 2021, the FDA announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Titled “Questions and Answers on Biosimilar Development and the BPCI Act,” the revised guidance aims to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars. The guidance also includes the FDA’s interpretation of certain statutory requirements added by the BPCI Act. In doing so, the FDA finalized some of the questions and answers (Q&As) that were previously in the first draft guidance document and moved them to the final guidance document.

This guidance finalizes all but 3 of the Q&As that were included in the draft guidance document, “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” issued on December 12, 2018. The FDA considered comments it received regarding these Q&As, and made changes to the Q&As, as appropriate; for example, providing additional and clearer information in Q.I.16 and providing additional information about text in the labeling for a biosimilar in Q.I.22. The FDA also made certain clarifying and editorial changes to update previously finalized Q&As. Editorial changes were made primarily for clarification.

The BPCI Act created an abbreviated licensure pathway in section 351(k) of the Public Health Service Act (42 U.S.C. 262[k]) for biological products shown to be a biosimilar to, or interchangeable with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act [Pub. L. 111-148]). The FDA believes that the guidance for industry that provides answers to commonly asked questions regarding the FDA’s interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products.

Individuals may submit either electronic or written comments to the docket the FDA has established for this Q&A guidance document (docket number: FDA-2011-D-0611).

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Last modified: December 23, 2021