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Biosimilars Post Market Regulation & Studies Regulation

Two Months To Add Two Words – Biosimilar Supplement Review Times May Be Hindering Uptake

  • Analysis

Executive Summary

Biosimilar supplement approvals by the US FDA take on average about five months as sponsors request easier and quicker ways to update labels.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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