Bipartisan Bill Seeks to Streamline Biosimilar Approvals, Lower Prescription Drug Costs
Key Insights
The Expedited Access to Biosimilars Act, introduced by Reps. Nick Langworthy and Kim Schrier, aims to eliminate duplicative clinical study requirements for biosimilar (search) approvals.
The legislation clarifies that the FDA may approve biosimilars without additional trials when existing evidence demonstrates safety and effectiveness, while preserving the agency's authority to require studies when necessary.
Biosimilars currently cost 15% to 35% less than brand-name biologics, and the bill seeks to accelerate patient access to these lower-cost alternatives for conditions including cancer (search) and autoimmune disorders (search).
Bipartisan legislation introduced July 15 by Congressman Nick Langworthy (NY-23) and Congresswoman Kim Schrier, M.D. (WA-08) aims to reduce regulatory hurdles for biosimilar (search) manufacturers, potentially accelerating patient access to lower-cost alternatives for biologic medicines used to treat cancer (search), autoimmune disorders (search), diabetes (search), and other serious conditions.
The Expedited Access to Biosimilars Act would clarify that the Food and Drug Administration (FDA) may approve a biosimilar (search) without requiring additional clinical studies when existing scientific evidence is sufficient to demonstrate safety and effectiveness. The agency would retain full authority to mandate further trials when necessary, and would be required to notify manufacturers early in the review process if such studies are needed.
"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 (search) 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."
The Biosimilar Landscape and Cost Burden
Biologics represent some of the most expensive prescription drugs on the market, with medicines treating cancer (search) and autoimmune disorders (search) carrying particularly high price tags due to extensive research and development costs. Under current law, once patents on these biologic drugs expire, other companies may develop biosimilars—products that the FDA must determine have no clinically meaningful differences from the original medicine in safety or effectiveness.
According to Langworthy's office, biosimilars typically cost 15% to 35% less than their brand-name counterparts. However, the lawmakers argue that duplicative clinical study requirements can add unnecessary costs and delay competition, even when existing scientific evidence already supports approval.
Key Provisions of the Legislation
The proposed bill contains three primary components. First, it clarifies that additional clinical trials are not required before the FDA approves a drug when existing evidence is sufficient. Second, it preserves the FDA's authority to require additional trials when necessary for safety. Third, it mandates that the FDA notify manufacturers early in the review process if additional trials will be required.
"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," Langworthy stated. "This is a commonsense reform that will increase competition, expand patient choice, and help reduce prescription drug costs for families."
Congresswoman Schrier, a practicing physician, emphasized that streamlining the approval process could improve access and lower drug prices for patients.
Broad Coalition of Support
The legislation has garnered backing from a diverse array of stakeholders across the healthcare ecosystem. Supporting organizations include Roswell Park Comprehensive Cancer Center, America's Health Insurance Plans (AHIP), the Campaign for Sustainable Rx Pricing (CSRxP), the Association for Accessible Medicines (search) (AAM), the ERISA Industry Committee (ERIC), the American Society of Health-System Pharmacists (search) (ASHP), and Americans for Prosperity (AFP), along with healthcare providers, patient advocates, employers, and insurers.
Candace Johnson, President and CEO of Roswell Park Comprehensive Cancer Center, noted that biosimilars account for a growing share of therapies used by cancer (search) centers, underscoring the clinical relevance of the proposed reforms for oncology practice.