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Regulators See Trend To Reduced Clinical Data Requirements For Biosimilars

This article was originally published in SRA

Executive Summary

The amount of clinical trial data needed to support a biosimilar drug application is declining as more experience is gained with biosimilar use and more use is made of increasingly sensitive analytical tools. Moreover, the concept of extrapolation of indications is gaining more credence, and the idea of immunogenicity as a particular problem with biosimilars seems to be losing traction.

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