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Sandoz’s Biosimilar Data-Bridging Plans For Zarxio Faced FDA Doubts

Executive Summary

FDA 'strongly encouraged' Sandoz to conduct three-way clinical PK/PD study comparing its Zarxio biosimilar to the EU- and U.S.-approved versions of Amgen’s Neupogen; however, the firm succeeded in using only analytical data to justify relevance of studies using the European reference product.

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