By Kate Rawson
As the final arbiter of an approval pathway for biosimilar products, the Food & Drug Administration is like a trapeze artist walking the high wire. The agency must carefully balance...
FDA's Balancing Act: Early Hints at a Biosimilars
FDA opened the regulatory phase of the biosimilar debate by hearing from industry and other stakeholders about what an approval system should look like. But this information-gathering session wasn’t all one-sided: FDA officials offered some hints of what they are thinking too. And while there are some significant areas of disagreement—and outlier positions—there was also quite a bit of common ground.