Sen. Rand Paul’s (R–Ky.) proposed Expedited Access to Biosimilars Act was unanimously voted out of the Senate Health, Education, Labor, and Pensions (HELP) Committee last week. This is good news.
Biosimilars are medications that are highly similar to biologic medications that have already been approved by the Food and Drug Administration (FDA). Biologic medications are drugs produced using living systems, such as microorganisms, plant cells, or animal cells. Examples include antibodies used to treat allergies, arthritis, or cancer, and GLP-1 agonists and VEGF inhibitors to help ameliorate maladies like diabetes and macular degeneration, respectively.
Paul’s legislation would permanently codify earlier Food and Drug Administration (FDA) guidance, making it easier for competing pharmaceutical manufacturers to get their own versions of biosimilars approved more quickly and at less expense. Even though biosimilar manufacturers make biologic medications that are essentially identical to brand-name drugs, the FDA has previously required them to conduct full clinical trials before winning approval.
Under the act, the agency would approve biosimilars if analytical tests show that patients metabolize them in much the same way as comparator brand-name compounds. As Paul points out, no biosimilar that has passed such testing has failed to gain FDA approval. In other words, biosimilar clinical trials are unnecessary redundant expenses.
In March, former FDA Commissioner Martin Makary estimated that these reforms could save biosimilar manufacturers up to $150 million in development costs and bring the drugs to patients two to four years earlier. Currently, biosimilars cost about 15 percent to 35 percent less than their respective brand-name compounds.
The introduction of biosimilars also generally prompts the brand-name manufacturers to lower prices for their drugs. Paul’s reforms would not only further speed up patient access, but also would likely result in even lower prices for these medications.
