Tim Kaine: “biologics, or complex large molecule drugs typically derived from living organisms, play a critical role in our…”

“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.…”