As a way to rein in the staggering amount of money that Americans spend on the complex drugs known as biologics each year, creating biosimilars as less-expensive alternatives makes sense. Europe has already approved 43 biosimilars; the U.S. just 11 of them. The U.S. will continue to lag behind in the development and use of biosimilars if Congress and the FDA require the “interchangeability” label for pharmacy substitution of reference biologics.
This interchangeability requirement is misguided on several levels, is counterproductive for the adoption of biosimilars, and will force Americans to pay billions of dollars more for these specialty drugs than they need to. The FDA’s role is to regulate drug approvals, not the practice of medicine, which it is veering into with the interchangeability requirement.