The Biosimilar User Fee Act (BsUFA) is vital to the regulatory review of biosimilar and interchangeable biosimilar products and the mission of the U.S. Food and Drug Administration (FDA) to protect and advance public health. Since its enactment in 2012, BsUFA has played an essential role in strengthening the FDA’s ability to implement a regulatory review approach that supports timely development of biosimilar biological products and is consistent with the Agency’s high standards for scientific rigor and patient safety. BsUFA III initiatives will build on the success of the program and help increase timely access to safe and effective biosimilars for patients.