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 biosimilars are introduced. As of the end of 2022, 40 biosimilars have been approved and there are 27 biosimilars on the market in the U.S. competing against ten brand biologics with several more scheduled to launch throughout 2023. Among these launched biosimilars are the first interchangeable biosimilar products, which may be substituted at the pharmacy counter without intervention from the prescriber, similar to many generic drugs. In addition, the FDA reported as of December 2022, there are over 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. As a result of increased launches and competition, the cumulative savings in total drug spending for classes with biosimilar competition are estimated to have reached $21 billion over the past 6 years, with much of this savings benefiting the Medicare Part B program.
Over the next five years, savings attributable to biosimilars are projected to exceed $180 billion, a more than four-fold increase from the last five years, with much of this savings benefiting the Part B program. However, future savings depend on a variety of factors that may influence the evolving landscape — including many of the misaligned payer incentives which impede uptake of biosimilars and the threat of the IRA chilling biosimilar competition in the years ahead.