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The University of Utah is very supportive of H.R. 5629. "Pathways for Biosimilars Act".

The Honorable James Matheson

United States House of Representatives

2434 Rayburn HOB

Washington, DC 20515

Dear Jim,

The University of Utah is very supportive of H.R. 5629. "Pathways for Biosimilars Act". H.R. 5629 has been several years in the making. It addresses challenges with getting FDA approval of Biological Medicines. Biological medicines (such as insulin or vaccines) are different from small-molecule drugs (such as aspirin or tetracycline) in that biologics are derivatives of living cells. Thus they often require more stringent analysis of responses from patients than do small-molecule drugs. To that end, an abbreviated pathway for drug approval through the FDA must embrace that aspect of biologics and potential Follow-on Biologics.

"Pathway for Biosimilars Act," H.R. 5629 recognizes the scientific requirements of proving safety and efficacy of each Follow-on Biologic. It provides the Commissioner of the FDA very clear measures for determining interchangeability so long as it can be proven safe in the current state of science and technology.

H.R. 5629 also is more amenable to the existing infrastructure for novel Biologic production in the legislation’s patent protection periods. The financial environment surrounding the development of biologic medications is fragile. For American researchers and developers to continue to compete in the global market for manufacturing new medications, patent protection for these products must be strong.

We would greatly appreciate it if you would co-sponsor this legislation. Your support will certainly help move the legislation so that we can accomplish the endeavor. Thank you very much for your help in the matter.

Best,

Kim Wirthlin

Vice President

VP Government Relations

University of Utah

JOHN R PARK BLDG

201 PRESIDENTS CIR RM 201

801/585-3159

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