Biosimilar biologics: is the US being left behind?

Approval of biosimilar biologics continues to be a topic of great interest as the push for accessibility to cheaper biologic medicines continues. Globally, the clear leader in the area is the European Medicines Agency (EMA), with the US Food and Drug Administration (FDA) lagging considerably behind. To look at these contrasting situations, one may think that Europe is taking one step forward, while the US takes two steps back.