The U.S. biologics and biosimilars market is evolving rapidly, and the benefits for patient access and controlling health care costs will continue to grow over time as more medicines are introduced. As of August 2022, 37 biosimilars have been approved—including three interchangeable biosimilars. 22 biosimilars are on the market in the U.S., competing against nine brand biologics. In addition, the FDA reported as of March 2022, there are nearly 100 biosimilars in development for which sponsors are paying BsUFA fees and benefiting from BsUFA-supported meetings with FDA, offering tremendous potential for biosimilars to continue to drive competition and savings in the years ahead.
Since biosimilars were introduced, the U.S. market has significantly evolved. In fact, the U.S. has approved more biosimilar products than the European Union had in a comparable period of time. This is largely due to the regulatory predictability and efficiencies that have been provided by the FDA’s successful implementation of the abbreviated approval pathway for biosimilars and the resources provided through BsUFA.
Owing to this successful framework, competition has become increasingly robust with annualized savings from biosimilars reaching $6.5B in 2020 and average sales prices for biosimilars reported to be as much as 45% less than brand biologics price at the time of first biosimilar launch. Biosimilars are also reaching much greater market uptake far quicker than earlier launched biosimilars, reflecting a maturing biosimilar market and continued positive shifts in provider and patient attitudes towards biosimilars. For example, in 2020 biosimilars competing against brand biologics in Medicare Part B garnered as much as 77% of the market driving significant savings for patients and Medicare.