Placeholder Banner

BIO Comments on "Considerations in Demonstrating Interchangeability with a Reference Product"

December 5, 2017

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Innovation Organization ("BIO") welcomes the opportunity to submit  comments on the Food and Drug Administration (FDA) draft guidance titled "Considerations in Demonstrating Interchangeability With a Reference Product" issued on January 18, 2017 ("Draft Guidance").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 Thus, we greatly appreciate FDA's issuance of the  long-awaited draft guidance on demonstrating interchangeability pursuant to section 351 (k)( 4) of the Public Health Service Act (PHSA) (42 U.S.C. 262(k)(4)). 

Download Full Comments Below
BIO Comments On Docket No. FDA-2017-D-0154 Draft Guidance On Considerati...
BIO Comments on Interchangeability
Discover More
We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated…
The Biotechnology Innovation Organization (BIO) is pleased to respond to the U.S. Department of Agriculture’s (USDA) Solicitation of Input from Stakeholders on Agricultural Innovations. BIO applauds USDA for taking a proactive approach and seeking…
July 31, 2020 Re: Docket No. FDA–2020-N-0837: Raare Disease Clinical Trial Network; Request for Information. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the…