US biosimilar activity rises, but is the first filing imminent?
This article was originally published in SRA
Executive Summary
With the launch of biosimilar Remicade in February marking another reference point in Europe's expanding biosimilars landscape1, the question arises: When can we expect the first biosimilar filing in the US? No one's saying, but the steady rise in sponsor-Food and Drug Administration activity over the past few years suggests it may not be long now.