The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under subsection 351(k) of the Public Health Service Act (PHSA). BIO supports the development of a well-constructed pathway for the approval of biosimilars, and acknowledges the Agency's request for comments on this matter as another important step in developing a transparent and effective regulatory framework for the review and approval of biosimilars.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, sustainable agriculture, and a cleaner and safer environment.
As a general matter, BIO agrees with FDA's statements in the May 10, 2011, Federal Register Notice (Notice) that existing user fee programs can inform the Agency's development of a user fee program for 351(k) applications, and that the establishment of user fees for products subject to the 351(k) pathway also presents unique challenges compared to existing programs. Below, we address FDA's proposed principles for development of a biosimilars user fee program, as well as FDA's proposed structure for this program.