The ongoing insulin cost crisis in the United States doesn’t look like it will be fully resolved any time soon, even as a few states have imposed caps on how much insurance companies can charge in co-pays for the drug. But a new rule change at the U.S. Food and Drug Administration (FDA) may lead to part of the solution, with the potential for new products to compete with existing versions of insulin.
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On March 23, the FDA announced that it would transition to treating insulin as a “biological product” rather than a standard drug for regulatory purposes. This change was mandated by Congress in a 2009 law, but only now has taken effect. In practice, this means that versions of insulin on the market already may soon face direct competition.
Under U.S. law, drug companies can get FDA approval for a “biosimilar” drug that’s modeled after an existing biologic drug if they can demonstrate that it’s “interchangeable” with the existing product. That means showing no difference in safety or effectiveness between the two products, usually based in part on a clinical study that compares actual outcomes in people using them.
Unlike standard drugs, the active components of biologic drugs (including insulin) are very large molecules that may vary slightly from batch to batch. These tiny differences shouldn’t change how the product is used or the effect it has. So unlike when a company proposes a generic equivalent to a standard drug, manufacturers that submit biosimilars for FDA approval don’t have do demonstrate that their active ingredient is identical to the original product. They just have to demonstrate “no clinically meaningful differences.”
This rule change for insulin means that now, drug manufacturers can make insulin that’s modeled after a brand-name product already on the market, compare the two versions in a clinical trial, and submit the new version for FDA approval as a biosimilar. Right now, the only insulin approved by the FDA that would fall under the new definition of biosimilar is Basaglar (insulin glargine), which is based on Lantus and was approved as a “follow-on” insulin, a term that is now obsolete.
“Today is a milestone for the future of insulin and other important treatments,” the FDA statement announcing the change reads. “We expect this regulatory transition to enable a vibrant competitive market for transitioning products, ultimately empowering patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications.”
Want to learn more about saving money on insulin? Read “Insulin Prices: Four Ways to Pay Less” and “Cheaper Insulin: Older Insulins May Be Answers to High Prices.”