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





 



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
<[link removed]>
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
<[link removed]>
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
<[link removed]> 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
<[link removed]> 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
<[link removed]>
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
<[link removed]>
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
<[link removed]>
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
patientsHERE
<[link removed]>
.



Read more on bipartisan, market-based solutions to hold Big Pharma accountable
HERE <[link removed]>.



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<[link removed]>