Biosimilars User Fee Act

The Biosimilars User Fee Act (BsUFA) is a law in the United States that allows the Food and Drug Administration (FDA) to collect fees from companies that create biosimilar medications. Biosimilars are products that are highly similar to existing biological drugs but are not identical. These fees help fund the review and approval process for new biosimilars, aiming to ensure they meet safety and effectiveness standards. By streamlining the approval process, the act encourages competition in the pharmaceutical market, which can lead to lower drug costs for patients.