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Take-it slow biosimilar approach by US FDA: best for industry?

This article was originally published in SRA

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 anticipated, according to Kim Greco, director of global regulatory and R&D policy at biotech giant Amgen.




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