Senators Budd, Hassan Introduce Bipartisan Bill to Lower Prescription Drug Prices for American Families
Washington, D.C. — U.S. Senators Ted Budd (R-N.C.) and Maggie Hassan (D-N.H.) introduced the bipartisan Biosimilar Inspection Modernization Act, legislation that would make prescription drugs more accessible and affordable by updating and improving the Food and Drug Administration’s (FDA) inspection processes for facilities manufacturing biosimilar medicines. Addressing these regulatory barriers would ultimately speed up the number of biosimilars brought to market, in turn increasing competition and lowering costs for patients.
“As prescription drug prices continue to climb, Americans with chronic illnesses are being forced to choose between the medications they need and paying their bills. By reducing regulatory bottlenecks on the inspections of facilities manufacturing low-cost biosimilars, we can help reduce the amount of time it takes for patients to gain access to these more affordable, safe, proven therapies. I am grateful to Senator Hassan for working with me on a solution that will make prescriptions more affordable for American families by removing regulatory barriers and increasing competition to brand name biologic drugs,” said Senator Budd.
“A key part of reducing prescription drug costs for families is helping more biosimilar and generic medications enter the market. The FDA should use every available resource to get biosimilar medications to patients more quickly. This bipartisan bill will cut red tape at the FDA, increase competition, and, in turn, lower prescription drug costs for Granite Staters and all Americans.” said Senator Hassan.
“The Biosimilars Forum strongly supports the Biosimilar Inspector Modernization Act, a critical piece of legislation that will ensure equity and uniformity to biosimilar reviews, creating consistency with other drug classes under FDA review and eliminating unnecessary bureaucracy. This legislation would not be possible without the leadership of Senator Budd and Senator Hassan. The Forum and our members thank the Senators and their staffs for spearheading this effort,” said Julie Reed, Executive Director, Biosimilars Forum.
The Biosimilar Inspection Modernization Act is endorsed by the Biosimilars Forum.
Read the full bill text HERE.
BACKGROUND
Biosimilars, the alternatives to brand-name biologics, offer a unique opportunity for reducing prescription drug costs for patients by bringing competition to brand name biologic drugs. Biosimilars are FDA approved and lower cost than their brand name competitors, but their market share remains below 20% in the United States.
Biosimilar Inspection Modernization Act of 2025:
Requires the FDA to develop a strategic plan for American biosimilars manufacturing, addressing FDA staffing challenges and improving internal and external communication.
Directs the improved use of Mutual Recognition Agreements, ensuring that unnecessary red tape is removed to bring these drugs to patients faster.
Updates the FDA’s inspection authorities to better utilize new tools and technologies in the oversight of biosimilar manufacturing facilities, so that the FDA more efficiently oversees these facilities.
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