This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation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 products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
The BPCI Act created an abbreviated licensure pathway in section 351(k) of the Public Health Service Act (PHS Act) for biological products shown to be 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) (ACA)). FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA’s interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products. In addition, these Q&As respond to questions the Agency has received from applicants regarding the submission of biologics license applications (BLAs) for biosimilar and interchangeable products. FDA may provide additional Q&As through draft guidance as appropriate.
The Q&As in this guidance will be finalized by adding them, as a revision, to the final guidance document Questions and Answers on Biosimilar Development and the BPCI Act as appropriate. The final guidance document is part of a series of guidance documents that FDA developed to facilitate development of biosimilar and interchangeable products.
The final guidance documents issued to date address a broad range of issues, including:
• Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (December 2016)
• Considerations in Demonstrating Interchangeability With a Reference Product (May 2019)
• Labeling for Biosimilar Products (July 2018)
• Questions and Answers on Biosimilar Development and the BPCI Act (Revision 1) (December 2018)
• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (April 2015)
In addition, FDA has published draft guidance documents related to the BPCI Act, which, when finalized, will represent FDA’s current thinking. These draft guidance documents include:
• Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (May 2019)
• Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products (June 2018)
• New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (December 2018)
• Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (August 2014)
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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