CSRxP APPLAUDS ADMINISTRATION FOR COMMITMENT TO FOSTERING GREATER BIOSIMILAR COMPETITION, LOWERING DRUG PRICES FOR AMERICAN PATIENTS
Efforts to Eliminate Red Tape and Boost Access to More Affordable Alternatives to High-Priced Brand Name Biologics Will Deliver Savings for Patients and the U.S. Health Care System
Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) today applauded an announcement by U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz to accelerate biosimilar approvals, boosting competition and lowering prescription drug prices for millions of Americans.
“CSRxP applauds the administration for taking steps to increase biosimilar competition and bring down costs for patients, taxpayers and the U.S. health care system,” said CSRxP executive director Lauren Aronson. “Actions to eliminate unnecessary red tape and streamline biosimilar approvals will help bring more affordable alternatives to market faster, boosting competition and delivering prescription drug savings for patients. Today’s announcement represents an important step toward strengthening competition in the prescription drug marketplace, expanding access to safe, effective, lower-cost treatments, and holding Big Pharma accountable for blocking more affordable options.”
The administration’s announcement includes new FDA guidance to eliminate comparative efficacy study requirements and streamline biosimilar approvals — a move that could significantly reduce barriers to fostering greater competition from more affordable alternatives to high-priced biologic drugs. The FDA also signaled support for automatically designating all biosimilars as interchangeable with their reference products and taking steps to increase domestic biosimilar manufacturing. Together, these efforts will help speed patient access to lower-cost treatments, expand the role of biosimilars in reducing drug spending across the health care system and add to a growing body of evidence that greater biosimilar competition can deliver substantial savings.
Learn more on how biosimilar competition reduces prescription drug costs and generates savings:
Out of Pocket Costs for Biosimilars 23 Percent Lower Than Reference Biologics
A March 2024 study published in JAMA Network compared out-of-pocket spending between seven biologics and their biosimilar alternatives. The study found that in the commercial market, average patient out-of-pocket costs for the biosimilars were 23 percent lower compared their reference biologic, or around $200 less, on average. According to the study, “the mean [out-of-pocket] costs were lower for biosimilars ($707) than reference biologics ($911).”
Biosimilar List Prices Are 15 to 35 Percent Lower Than Branded Biologics
According to a July 2021 FDA press release announcing approval of the first interchangeable biosimilar insulin product for diabetes, biosimilar drugs launched in the United States typically have “initial list prices 15% to 35% lower than comparative list prices of the reference products.”
Projected Savings of Greater Biosimilar Competition Between 2021 and 2025: $38.4 Billion
A July 2022 paper in the American Journal of Managed Care found that estimated savings from increased biosimilar competition and uptake could result in savings of $38.4 billion for the U.S. health care system. According to the paper’s authors, most of the expected savings will be driven “by downward pressure on the brand-name biologics they compete with.”
Generic and Biosimilar Savings in 2022: $445 Billion
A September 2024 report from The Association for Accessible Medicines found that generics and biosimilars together led to savings of $408 billion in the U.S. health care market in 2022, an increase of $35 billion from the year prior. The report notes that savings from generics and biosimilars have consistently increased by seven to 10 percent per year.
Generics and Biosimilars Make Up 90 Percent of All Prescriptions But Less Than 18 Percent of Spending
The same September 2023 report from The Association for Accessible Medicines found that despite making up more than 90 percent of all prescriptions in the U.S. market, generic and biosimilar drugs accounted for less than 18 percent of spending on all prescriptions.
American Voters Broadly Support Improving Competition And Access To Biosimilars
A February 2025 national poll of U.S. voters, conducted By Fabrizio Ward on behalf of the Campaign for Sustainable Rx Pricing (CSRxP), found 82 percent of voters support “reform[ing] patent laws to prevent drug companies from abusing the system that extends their monopolies longer than intended and halts lower cost generic drugs and biosimilars from the market.”
Read more about how biosimilar competition lowers out-of-pocket costs for patients HERE.
Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.
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