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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.

Hurdles for biosimilars were originally set up by Congress, but the FDA has historically gone a step further by taking an overly cautious approach. For example, the FDA requires biosimilar developers to conduct comparative clinical studies — something th

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