This 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 biosimilars and interchangeable biosimilars, as well as to describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
The BPCI Act amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the 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 prospective applicants regarding the appropriate statutory authority under which certain products will be regulated. FDA intends to update this guidance document to include additional Q&As as appropriate.
This guidance document revises the final guidance document entitled Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, to clarify and update certain Q&As and to add new Q&As. For certain Q&As, FDA has updated the Q&A by abbreviating the answer and, where appropriate, referring the reader to a separate guidance document that provides additional information on the topic. Alternatively, FDA may have withdrawn a Q&A if the topic is addressed in a separate guidance document or if FDA determined that the Q&A should be revised in some respect and reissued. Additional information about the Q&A format for this guidance document is provided in the Background section.
FDA is also issuing a draft guidance document entitled New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2). When finalized, this draft guidance document will be part of a series of guidance documents that FDA has developed to facilitate development of biosimilar and interchangeable products. The final guidance documents issued to date address a broad range of issues, including:
- Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product (April 2015)
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (April 2015)
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (December 2016)
- Labeling for Biosimilar Products (July 2018)
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:
- New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (December 2018)
- Considerations in Demonstrating Interchangeability With a Reference Product (January 2017)
- Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products (June 2018)
- Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (August 2014)