US FDA should look to the EU for guidance on biosimilars
This article was originally published in SRA
Executive Summary
It seems that the US could learn a lot about biosimilars from the EU, the world's biggest and most advanced market in this area. While the US is still struggling to set in motion its 2009 Biologics Price Competition and Innovation Act, the EU is already moving ahead on how to deal with large-molecule biosimilars.
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