The U.S. FDA on Wednesday issued draft guidance that aims to accelerate the process for getting biosimilar drugs — essentially generic versions of pricey biologic-based medicines — to consumers.
The plan is to “simplify” studies that establish bioequivalence and “reduce unnecessary clinical testing,” per a news release.
While biologic therapies made up 5% of prescriptions in 2024, it accounted for 51% of total drug spend, according to the agency. Many biologic drugs are used to treat conditions including cancers, autoimmune disorders, and rare diseases.
Currently, 76 biosimilar therapies have been approved. However, just 10% of brand biologics slated to go off patent in the next 10 years have a biosimilar in development.
“Today’s announcement of biosimilar reform furthers President Trump’s directive to lower drug prices for the American people,” HHS Secretary Robert F. Kennedy Jr. said in a statement. “Biologics treat many chronic diseases, but for too long, a burdensome approval process has kept patients from accessing more affordable biosimilars.”
The present method for getting a biosimilar approved typically takes between one and three years with a $24M average costs on average and requires comparative efficacy studies, according to the FDA.
“The FDA’s new guidance reduces this unnecessary resource-intensive requirement for developers to conduct comparative human clinical studies, allowing them to rely instead on analytical testing to demonstrate product differences,” the agency said.