WHY BIOSIMILARS
We are a nonprofit dedicated to expanding access to life-saving biosimilar drugs. We work with policymakers and stakeholders to create public policies that encourage biosimilar awareness and education and increased use.
A biosimilar is a biologic medicine that is approved based on a demonstration that it is highly similar to an FDA-approved biological medicine. These therapies are a commonsense solution to rising prescription drug costs and a lower-cost alternative to the most expensive drugs in our healthcare system. Nearly 30% of Americans say they haven’t taken their medication as prescribed due to unaffordable prices.
The introduction of biosimilars in the United States may help expand access to high-quality treatment options for clinicians and patients as well as potentially reduce costs to families, caregivers, payers, and the entire health care system. There are currently 77 biosimilars with FDA-approval, 48 on the market and many more on the way.
Biosimilars Void
Over the next decade, 118 biologics are expected to lose patent protection, and biosimilars could offer significant cost-savings for each of these. This includes a significant wave of oncology drugs, which could lower costs for cancer patients. Of the 118 biologic patent expiries over the next decade, only 10 percent currently have biosimilars in development, while 90 percent have no biosimilar in the pipeline. This void in the biosimilar market significantly limits savings potential to the healthcare system.
If all products with a patent expiring in the next 10 years were to have a biosimilar in the pipeline, the U.S. healthcare system could save an additional $189 billion in addition to savings generated by biosimilars already on the market or expected to enter. The biosimilar market must maintain stability to avoid losing the savings and affordability benefits for the healthcare system and patients. To ensure this, it’s imperative that barriers to access are addressed by the Trump Administration and Congress.
Cost Savings
In the last ten years, biosimilars have been associated with savings of $56 billion compared to what spending would have been without biosimilars. The next five years could see an increase in savings up to $181 billion as newly approved biosimilars launch and existing biosimilars see continued uptake.
Biologic drugs—some of the most expensive drugs available—are estimated to cost Medicare Part B and its enrollees upwards of $32 billion annually. Making biosimilars more available to the Medicare program billions of dollars each year.
Prices continue to increase for biologic drugs. These medications represented 46% of U.S. prescription drug spending in 2022, despite only making up 3% of prescriptions. For context, the U.S. spent $568 billion on pharmaceuticals in 2021—and $260 billion went toward biologics. With lower-cost biosimilars available, this is an affordability crisis for Americans that can easily be addressed.
In addition to increasing access to lower-cost medicines, biosimilars provide cost-savings for government healthcare programs and eliminate wasteful government spending. President Trump, his Administration, and this Congress have the opportunity to utilize cost-savings from biosimilars to solidify Medicare’s funding.
Biosimilars are, on average, more than 50% lower-cost than their reference biologics—despite no clinical differences in safety and efficacy. This means more competition, lower prices, and better access to beneficial drugs—exactly the kind of free-market solutions President Trump promised.