Insights
FDA Issues Continued Guidance on Biosimilar Development and the BPCIA
The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product. The FDA periodically issues non-binding guidance documents to provide the public with FDA's current thinking on a topic, and has issued a number of BPCIA-related guidance documents in a question-and-answer (Q&A) format. In the agency's words, “The Q&A format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, and also describe the FDA's interpretation of certain statutory requirements added by the BPCI Act." Guidance on a particular question is initially issued in draft form and is open for public comment. After reviewing comments, the FDA issues final guidance, which replaces the draft guidance provided in an earlier document on a question-by-question basis.
On September 20, 2021, the FDA issued its latest guidance documents on biosimilars and the BPCIA, providing final guidance on five of the Q&As that remained in draft form in the prior guidance. Specifically, the document Questions and Answers on Biosimilar Development and the BPCI Act provides answers in final form to the following questions.
*Questions are verbatim from the FDA, summaries are written by Choate, Hall & Stewart LLP
Additionally, the FDA withdrew certain draft questions. One withdrawn question addressed a process for obtaining certain letters related to reference product access for testing for products with risk evaluation and mitigation strategy with elements to assure safe use. Following enactment of the Further Consolidated Appropriations Act, 2020 (FCA), which includes provisions related to this topic, the FDA intends to issue guidance describing how the existing process for obtaining these letters is being aligned with the framework set forth in the new law.
The FDA also withdrew a question that addressed the definition of "protein'' as used in section 351(i)(1) of the PHS Act. The BPCIA amended the definition of "biological product" to include a "protein (except any chemically synthesized polypeptide)", and the question addressed the meaning of both "protein" and "chemically synthesized polypeptide". However, while the question was pending in draft form, the FCA eliminated the parenthetical phrase, rendering final guidance on its meaning unnecessary. Accordingly, applicants should look to the final rule entitled Definition of the Term "Biological Product", 85 Fed. Reg. 10057 (February 21, 2020), 21 C.F.R. § 600.3(h)(6)), for the definition of "protein" as used in the PHS Act.
If you have questions regarding these developments, please contact a member of our Biosimilar team.