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.
By Kate Rawson
As the final arbiter of an approval pathway for biosimilar products, the Food & Drug Administration is like a trapeze...
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