Many cutting-edge medicines come with sky-high price tags, leaving patients struggling to afford them. Biosimilars were introduced to help fix this problem. Think of them as the “generic” versions of complex biological medicines. They provide the same life-saving benefits at a much lower cost. Just as generic drugs made everyday medications more affordable, biosimilars are now driving down the cost of complex therapies ranging from insulin to cancer treatments. That means more affordable access to essential medicines saving patients billions of dollars. However, there are still unnecessary barriers set up by the Food and Drug Administration (FDA) preventing biosimilars from being prescribed and discouraging drug manufacturers from developing them in the first place.
In the U.S., biosimilars can’t automatically be substituted for the brand-name biologic like generics can. That’s because the FDA created a tougher standard for biosimilar interchangeability—switching a brand name biologic prescription for a biosimilar version—than for traditional small molecule drugs. To receive an interchangeable biosimilar designation always required expensive and often redundant switching studies until recently. These are studies of what happens when patients switch between biosimilars and the original that are not required for other medicines. Without this stamp of approval, most pharmacists are barred by law from swapping in a biosimilar even if it’s cheaper and proven just as effective.
When biosimilars were new these studies made sense—be thorough when testing new technology. But time has shown restriction is unnecessary. Europe dropped the requirement already, leading to more available biosimilars for patients compared to the U.S. The FDA has recently proposed easing this requirement, and has even approved several biosimilars as interchangeable without switching studies. But until those changes are finalized, biosimilar manufacturers do not know if they will face switching studies or not, and the market remains tilted in favor of pricier brand-name drugs.
Another hurdle is how these drugs are named. The FDA forces biosimilars to carry a unique four-letter suffix, unlike for small molecule drugs. So, a biosimilar of Humira might be labeled as “adalimumab-fkjp,” while the original is just “adalimumab.” That small difference sends a not-so-subtle message to prescribers that the drug isn’t quite the same. It’s a bureaucratic decision with real-world consequences, one that creates doubt where none should exist and undermines confidence in a product designed to lower costs and expand access.
Unsurprisingly, that doubt has taken root. Many physicians remain hesitant to prescribe biosimilars. This is especially true when treating patients who are already stable on a brand-name biologic, despite overwhelming data showing biosimilars are just as safe and effective, without danger in switching. When trust is eroded by regulation rather than evidence, patients lose and are stuck with higher drug costs simply because the system makes the cheaper, equally effective option harder for physicians and patients to choose.
All of this amounts to a brutal accounting problem for would-be biosimilar developers. Companies must spend hundreds of millions and nearly a decade to bring a biosimilar to market, only to face regulatory red tape, naming policies that cast doubt on their product, and doctors hesitant to prescribe it. Worse, even after clearing those hurdles, they still aren’t granted an interchangeability label, so pharmacists can’t substitute their product at the counter. As a result, investors steer clear causing biosimilar research pipelines to dry up and cheaper alternatives never get made. Patients and payers are stuck footing the bill for a monopoly price that could have ended years earlier.
Fixing this doesn’t require new laws, just smarter regulation. If the FDA fully dropped the costly switching study guidance and made all approved biosimilars automatically interchangeable, manufacturers wouldn’t be gambling every time they develop a new biosimilar. That alone would lower the barrier to development, opening the door for more lower-cost treatments for patients. Combine that with scrapping the stigmatizing naming conventions eliminates artificial confusion that sows doubt proven products. More biosimilars and lower costs mean patients could finally see real price competition at the pharmacy counter for some of the most expensive medicines.
Most importantly, this would make doctors more confident in prescribing biosimilars from day one and pharmacists would be able to substitute for less expensive medicines when prescriptions are filled. That shift in trust could fix the current situation where cheaper drugs exist but sit unused. Patients would no longer be stuck paying inflated prices simply because less expensive version of their medicine was buried by red tape. It’s a rare fix in health care that’s simple, cost-saving, and pro-patient all at once.
Justin Leventhal is a senior policy analyst for the American Consumer Institute, a nonprofit education and research organization that advocates for consumers through evidence-based analysis and data. Visit www.TheAmericanConsumer.Org or follow us on X @ConsumerPal.
