Last year, 43% of U.S. adults did not take their medication as prescribed because of the cost of prescription drugs. These rising drug prices hit American seniors, small businesses, and middle-class families the hardest.
The bulk of these costs are due to biologic medicines. While biologics make up only 5% of our country’s prescriptions, they account for 51% of prescription drug spending. In fact, patient and taxpayer spending on biologics has increased from $100 billion to $260 billion over the last decade.
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Millions of Americans depend on biologic medicines to manage chronic conditions like rheumatoid arthritis, cancer, diabetes, and Crohn’s disease. Hard-working Americans need to be able to afford them.
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FDA-approved biosimilars are the commonsense, bipartisan answer to the prescription drug affordability crisis.
Biosimilars are safe and effective. They cost up to 50% less than reference biologics, leading to significant savings for patients, the Medicare program, and taxpayers. While biosimilars have saved the U.S. healthcare system $56 billion, they have the potential to save an additional $181 billion in the next five years with more approvals, access, and competition.
Congress must pass the Red Tape Elimination Act to ensure biosimilars are able to provide the cost savings they promise. This legislation would designate all FDA-approved biosimilars as interchangeable. It would also eliminate a major barrier to biosimilar access by removing the one-year market exclusivity period currently granted to the first biosimilar to receive the interchangeable designation.
These barriers to access have led to real harms for U.S. patients. A 2025 study conducted by Eastern Research Group for the Department of Health and Human Services found that the current biosimilars interchangeability distinction has contributed to poorer market uptake in the United States compared to generic drugs.
The current one-year market exclusivity period delays free market competition, props up prices of already expensive biologics, and discourages free-market competition. More biosimilars available on the marketplace means patients have increased lower-cost options to choose from.
The interchangeable distinction that exists today for biosimilars has sown unnecessary confusion among patients, physicians, and pharmacists. Distinguishing interchangeable biosimilars from other approved biosimilars creates a false perception that some biosimilars are safer or more effective than others.
The Red Tape Elimination Act ends that confusion by aligning U.S. law with science. The European Medicines Agency and other major global regulators already consider all biosimilars interchangeable. This has improved uptake and avoided the uncertainty that plagues biosimilars in the U.S. system.
The Red Tape Elimination Act would also allow for biosimilar substitution by pharmacists at the counter without a new prescription, like a generic. Currently, this is only allowed for interchangeable biosimilars, adding unnecessary red tape for patients accessing the lower-cost drugs they need.
Passing this legislation is especially time-sensitive because of the looming “biosimilar void.” Of the 118 biologics expected to lose patent protection over the next decade, only 10% currently have biosimilars in development.
This void would be addressed by ensuring manufacturers their biosimilars will receive market access.
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As the leaders of the U.S. biosimilars industry, the Biosimilars Forum members have made a commitment to bring lower-cost biosimilars to patients who need them. Supporting the Red Tape Elimination Act and calling for its passage is another example of their goal to further cost savings through free-market competition.
It’s long overdue for U.S. law to follow two decades of scientific experience. The Red Tape Elimination Act achieves this.
Juliana Reed is the Biosimilars Forum’s executive director.
