Interchangeable Biologics Clarity Act

Mr. President, the Food and Drug Administration's ``Purple Book'' provides patients, providers, and public health experts with key information about FDA-licensed biological products. Providers rely on accurate and up-to-date information from this searchable online database to make crucial decisions regarding the treatment of their patients. The ``Purple Book'' provides transparency on the availability of biological products. This can help inform public health decision- making and increase competition among manufacturers to lower prices. Improvements to the ``Purple Book'' clarifying when biological products leave the market would allow the FDA and the public to monitor the availability of these key medications.

That is why I am proud to join my colleagues, Senators Marshall, Hassan, and Cassidy, in introducing the Biologics Market Transparency Act, legislation that would extend to biological products certain reporting and transparency requirements that already exist for small molecule drugs. This is the Senate companion to legislation introduced by Representatives Kathy Manning and Richard Hudson in the House. It would require manufacturers of biological products to confirm that their products listed in the ``Purple Book'' are available for sale. This bill would also require manufacturers to report to the Secretary of Health and Human Services when their products are withdrawn from the market. These updates to the ``Purple Book'' would provide patients and providers with real-time access to changes in drug availability, allowing physicians to make informed decisions about the best treatment for their patients. These changes would also improve the ability of the FDA to respond to and anticipate drug shortages.

I look forward to working with my colleagues to pass these commonsense reforms to strengthen public health and increase transparency for patients and providers.

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

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.

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

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.