The U.S. Food and Drug Administration has announced significant reforms to reduce the regulatory burden on biosimilar drug approvals, with the goal of significantly lowering prescription drug costs for Americans. Biosimilars are ‘generic’ versions of expensive biologics, a class of medicines that can cost up to $200,000 annually. The reforms seek to remove unnecessary clinical trial requirements, which have historically delayed the introduction of these lower-cost options.
The fastest-growing area of health care spending is prescription drugs. Leading the way is an expensive class of medicines called biologics, which commonly cost up to $200,000 annually. There are ‘generic’ versions of these medications, called biosimilars, which have the potential to save Americans billions of dollars, but their use has been hindered by unnecessary bureaucratic hurdles. We are taking action to fix this broken system to deliver lower drug prices for Americans.