Reps Schrier, Langworthy Introduce Bipartisan Bill to Lower Prescription Drug Costs by Expanding Access to Biosimilars

WASHINGTON, D.C. – Congresswoman Kim Schrier, M.D. (WA-08) and Congressman Nick Langworthy (NY-23) recently introduced the Expedited Access to Biosimilars Act, bipartisan legislation to modernize the Food and Drug Administration's (FDA) biosimilar approval process, reduce unnecessary regulatory barriers, and help bring lower-cost prescription drugs to patients faster.

 “As a doctor with Type 1 diabetes, I have seen firsthand how skyrocketing insulin prices have threatened access to lifesaving medication for too many Americans,” said Congresswoman Schrier. “It is past time the Food and Drug Administration improve the approval process for biosimilars, which are lower-cost, lifesaving, and effective treatments. I am glad to introduce this legislation to streamline the FDA’s process, lower drug prices, and make medicine more accessible for patients across the country.”

BACKGROUND: Biologics are among the most advanced medicines available, treating serious conditions including cancer, arthritis, Crohn's disease, diabetes, and autoimmune disorders. Because of the extensive research and development costs that are associated with these cutting-edge treatments, they are among the most expensive drugs on the market. However, once the patent on a biologic expires, manufacturers can develop a biosimilar, which the FDA must determine has no clinically meaningful differences from the original medicine in terms of safety or effectiveness. Biosimilars create competition in the marketplace and typically cost 15 to 35 percent less than their brand-name counterparts.

Although the FDA already requires extensive scientific evidence before approving a biosimilar, manufacturers are often expected to conduct additional clinical studies even when existing evidence demonstrates the biosimilar is just as safe and effective as the original product. Those unnecessary studies can cost millions of dollars, delay competition, and keep lower-cost treatment options out of patients' hands.

The Expedited Access to Biosimilars Act eliminates unnecessary regulatory hurdles while preserving the FDA's authority to require additional clinical studies whenever they are scientifically warranted.

"Americans deserve access to safe, effective, and more affordable prescription drugs, and one of the best ways to lower costs is by encouraging competition," said Congressman Langworthy. "Today, biosimilar manufacturers are often forced to complete duplicative clinical studies even when the science already demonstrates their products are just as safe and effective as the original biologic. Our bipartisan bill cuts unnecessary red tape, provides greater regulatory certainty, and helps bring lower-cost treatment options to patients faster without compromising the FDA's rigorous safety standards. This is a commonsense reform that will increase competition, expand patient choice, and help reduce prescription drug costs for families."

The legislation would:

• Clarify that additional clinical studies are not automatically required before the FDA may approve a biosimilar when existing scientific evidence is sufficient.
• Preserve the FDA's authority to require additional clinical studies whenever they are necessary to ensure a biosimilar is safe and effective.
• Require the FDA to notify manufacturers early in the review process if additional clinical studies will be required, providing greater certainty and helping avoid unnecessary delays.

The legislation is supported by a broad coalition of healthcare providers, patient advocates, employers, insurers, and biosimilar manufacturers, including Roswell Park Comprehensive Cancer Center, America's Health Insurance Plans (AHIP), the Campaign for Sustainable Rx Pricing (CSRxP), the Association for Accessible Medicines (AAM), the ERISA Industry Committee (ERIC), the American Society of Health-System Pharmacists (ASHP), and Americans for Prosperity (AFP).