BIO Comments on "Considerations in Demonstrating Interchangeability with a Reference Product"
The Biotechnology Innovation Organization ("BIO") welcomes the opportunity to submit comments on the Food and Drug Administration (FDA) draft guidance titled "Considerations in Demonstrating Interchangeability With a Reference Product" issued on January 18, 2017 ("Draft Guidance").
BIO represents more than 1,000 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, and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
Implementation of the Biologics Price Competition and Innovation Act ("BPCIA") remains of significant importance to BIO members. Thus, we greatly appreciate FDA's issuance of the long-awaited draft guidance on demonstrating interchangeability pursuant to section 351 (k)( 4) of the Public Health Service Act (PHSA) (42 U.S.C. 262(k)(4)).