Placeholder Banner

Biosimilars: BIO Comments on FDA Draft Guidance Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009

August 30, 2016
Re: Draft Guidance for Industry: Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Docket No. FDA-2015-D-4750 (March 14, 2016))
 
The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit comments on the Food and Drug Administration’s (“FDA’s”) draft guidance entitled “Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009” issued on March 14, 2016 (“Draft Guidance”).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”) is of significant importance to BIO members, and we greatly appreciate FDA’s efforts to provide clarity on the agency’s current thinking on the transition provisions. As detailed below, we do have concerns about the agency’s proposed interpretations of the provisions as outlined in this Draft Guidance. In finalizing the Draft Guidance, we strongly urge the agency to consider our comments and requested changes.
Download Full Comments Below
BIO Comments On Draft Guidance For Industry- Implementation Of The Deemed To Be A License Provision
Read the Full Comments Below
Discover More
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…
July 30, 2020 Re: Docket No. FDA–2019-D-5799: FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or…