A bipartisan bill in the House aims to modernize the FDA's approval process for biological medication, reduce unnecessary regulatory barriers, and help bring lower-cost prescription drugs to patients faster. Western New York Republican Nick Langworthy and Washington Democrat Kim Schrier have introduced the Expedited Access to Biosimilars Act, which Langworthy says is a "common sense reform that will increase competition, expand patient choice, and help reduce prescription drug costs for families."
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 15-35% 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. Langworthy says those studies are unnecessary and can cost millions of dollars, delay competition, and keep lower-cost treatment options out of patients' hands.
The Expedited Access to Biosimilars Act would eliminate unnecessary regulatory hurdles while preserving the FDA's authority to require additional clinical studies whenever they are scientifically warranted. 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 health care providers, patient advocates, employers, insurers and biosimilar manufacturers; among them is the Roswell Park Comprehensive Cancer Center.
