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.
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. Follow Justin on X @JustinLeventhal.