By Jeffrey H. Brochin, J.D.
The FDA has provided some answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). In a draft guidance titled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)," the FDA uses a question and answer format to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, as well as to describe the FDA’s interpretation of certain statutory requirements added by the BPCI Act (Notice, 83 FR 63898, December 12, 2018).
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 (passed as sections 7001 through 7003 of the Patient Protection and Affordable Care Act (ACA) (P. L. 111–148)). The FDA believes that 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. In addition, the Q&As respond to questions the agency has received from prospective applicants regarding the appropriate statutory authority under which certain products will be regulated. The FDA intends to update the draft guidance document to include additional Q&As as appropriate.
Defining ‘similar’ and ‘biosimilar’. Section 351(i) of the PHS Act defines the term biosimilar, or biosimilarity, in reference to a biological product that is the subject of an application under section 351(k) to mean "that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and that "there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product."
Upon review of an application submitted under section 351(k) or any supplement to such application, the FDA will determine the biological product to be interchangeable with the reference product if the FDA determines that the information submitted in the application (or a supplement to such application) is sufficient to show that the biological product "is biosimilar to the reference product" and "can be expected to produce the same clinical result as the reference product in any given patient" and that "for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch."
Q&A companion to previous guidance. The draft guidance is a companion to the FDA’s final guidance document entitled Questions and Answers on Biosimilar Development and the BPCI Act. The final guidance document is part of a series of guidance documents that the 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)
- Questions and Answers on Biosimilar Development and the BPCI Act (December 2018)
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (December 2016)
- Labeling for Biosimilar Products (July 2018)
In addition, the FDA has published draft guidance documents related to the BPCI Act, which, when finalized, will represent the FDA’s current thinking.
Electronic or written comments on the draft guidance may be submitted by February 11, 2019 to ensure that the FDA considers comment on the draft guidance before it begins work on the final version of the guidance.
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