FDA's take-it-slow biosimilars approach: best for industry?
This article was originally published in Scrip
Executive Summary
Even though Congress put in place clear criteria when it wrote the Biologics Price Competition and Innovation Act (BPCIA), the task of actually approving biosimilars in the US has turned out to be much more complicated than lawmakers may have realized, said Kim Greco, director of global regulatory and R&D policy at Amgen.