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US FDA Panel Nod For Celltrion's Biosimilar Signals Acceptance For Data Extrapolation

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration's Arthritis Advisory Committee has overwhelmingly endorsed approval of Celltrion Inc.'s biosimilar Inflectra (CT-P13) and has urged the agency to recognize the concept of data extrapolation1,2.

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