Regulatory policy may not stop comparative efficacy trials

Center for Biosimilars

4 November 2020 - The way Sarfaraz K. Niazi, looks at it, doing comparative efficacy studies in humans to confirm that a biosimilar candidate is equivalent to a reference product is, in most cases, a complete waste of time. But many biosimilar companies still do these studies. 

The reason? The comparative clinical data may have little value in getting regulators to approve their products, despite helping with future marketing.

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Michael Wonder

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Michael Wonder

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US , Regulation , Biosimilar , Comparison