[Congressional Record Volume 168, Number 91 (Wednesday, May 25, 2022)]
[Senate]
[Pages S2709-S2710]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KAINE (for himself and Ms. Collins):
  S. 4303. A bill to provide for a period of exclusivity for first 
interchangeable biological products; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. KAINE. Mr. President, biologics, or complex large molecule drugs 
typically derived from living organisms, play a critical role in our 
healthcare system, treating a range of conditions such as diabetes, 
arthritis, and cancer. Yet spending on these products accounts for an 
alarming and significant portion of overall drug spending in the United 
States. In 2018, biologics accounted for 40 percent of spending on all 
prescription drugs, with spending on biologics growing twice as quickly 
as overall drug spending since 2015.
  Biosimilars are drugs that are highly similar to existing biologics, 
and interchangeable biosimilars are biosimilars that can be substituted 
for a biologic product without the intervention of a healthcare 
provider. Biosimilars and interchangeable biosimilars can play a 
significant role in reducing drug spending. For example, Medicare Part 
D spending for both beneficiaries and the program is less than spending 
on reference biologic products even as the use of biosimilars increases 
with increased availability. As of April 2022, there were 33 biosimilar 
products on the market including interchangeable

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biosimilar products. Food and Drug Administration, FDA, approval of 
additional interchangeable biosimilars could provide patients with more 
treatment options, increase competition, and lower costs. We must take 
steps to provide clarity around the FDA's review process for 
interchangeable biosimilars to facilitate development of these 
products, bringing them to market faster.
  That is why I am proud to join my colleague, Senator Collins, in 
introducing the Interchangeable Biologics Clarity Act, legislation that 
would make key improvements in the FDA's review process for 
interchangeable biosimilars. Specifically, this bill would clarify the 
FDA's authority to tentatively approve a second or third 
interchangeable before the end of the first interchangeable's 
exclusivity period, allowing additional products to enter the market 
more efficiently when that exclusivity period ends. This legislation 
would also specify that two interchangeable biologics approved on the 
same day could share an exclusivity period. These provisions would 
allow the FDA to issue additional guidance around the review of 
interchangeable biologic products and ensure increased transparency 
about the exclusivity periods for interchangeable products.
  I look forward to working with my colleagues to pass these important 
improvements to the FDA's biosimilar review process that will increase 
patients' treatment options and help foster competition.

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