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Testimony of Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization

March 2, 2017

Testimony of Kay Holcombe, Senior Vice President, Science Policy,
Biotechnology Innovation Organization

United States House of Representatives

Energy and Commerce Committee, Subcommittee on Health

Hearing on “Examining FDA’s Generic Drug and Biosimilar User Fee Programs”

Mr. Chairman, Ranking Member Green, and Members of the Subcommittee,

What an honor it is to speak to you today on behalf of the Biotechnology Innovation Organization (BIO) about the Biosimilars User Fee Act reauthorization. This Committee planted the seed that has grown into multiple user fee programs that provide FDA with a significant portion of the resources it needs to ensure that patients have timely access to safe and effective new drugs and biologics, generic drugs, biosimilars, and medical devices. This Committee also tilled the ground and successfully produced, with an overwhelming bipartisan House vote, the legislation that established an FDA pathway for the approval of biosimilars – the Biologics Price Competition and Innovation Act (BPCIA). BIO was an early and strong supporter of this legislation to create a facilitated and balanced pathway for greater competition in the biologics marketplace.

I am Kay Holcombe, the Senior Vice President for Science Policy at BIO. BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. While our membership includes most of the large biopharmaceutical companies, the vast majority of our members are small biotechnology companies working on the most cutting-edge R&D. They have small staffs, no marketed products, and no profits, and they are heavily reliant on private capital to fund their work. They take enormous risks every day to develop the next generation of biomedical breakthroughs for the millions of patients suffering from diseases for which there are no effective cures or treatments today. BIO is proud of their innovative spirit and their dedication to alleviating human suffering.

You asked for our views on two proposals the Committee is considering: the Biosimilars User Fee Act and H.R. 749, the Lower Drug Costs through Competition Act. In summary, BIO strongly supports the reauthorization of BsUFA, as we supported the initial enactment of the BPCIA and the initial BsUFA program. We also want to express support for competition in the prescription drug marketplace not only between innovator biologics and biosimilars, but also between innovator drugs and generic drugs – which is the subject of H.R. 749. We believe that, in both cases, our shared ultimate goal is achieved – to provide patients with greater access to therapies that save and improve their lives.

As BIO’s lead negotiator for the BsUFA process, I want to focus my comments today principally on thisreauthorization. As BIO considered this approaching reauthorization in consultation with our membersand other stakeholders, we coalesced around two over-arching goals. First, we want to ensure that FDAwill have the resources over the next five years of the BsUFA program to accomplish the fundamentalobjectives of the program, including clarifying further and enhancing the processes and tools the agencyuses to regulate biosimilars. Second, we want to improve the transparency, financial accountability, andsustainability of the BsUFA program. We believe the BsUFA reauthorization proposal meets these twogoals...

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