Beschreibung:
<jats:p>For regulatory review and approval of biosimilar products, the United States (<jats:styled-content style="fixed-case">US</jats:styled-content>) Food and Drug Administration (<jats:styled-content style="fixed-case">FDA</jats:styled-content>) recommended a stepwise approach for demonstrating biosimilarity between a proposed biosimilar product and an innovative (reference) biological product (e.g., an <jats:styled-content style="fixed-case">US</jats:styled-content>‐licensed product).<jats:sup>1–3</jats:sup> The stepwise approach is to provide totality‐of‐the‐evidence for demonstrating biosimilarity between the proposed biosimilar product and the reference product. The stepwise approach starts with analytical studies for functional and structural characterization of critical quality attributes (<jats:styled-content style="fixed-case">CQAs</jats:styled-content>) at various stages of manufacturing process. For the assessment of analytical similarity of <jats:styled-content style="fixed-case">CQAs</jats:styled-content>, <jats:styled-content style="fixed-case">FDA</jats:styled-content> suggests, first, identifying the <jats:styled-content style="fixed-case">CQAs</jats:styled-content> that are relevant to clinical outcomes, and then classifying the identified <jats:styled-content style="fixed-case">CQAs</jats:styled-content> into several tiers depending upon their criticality or risk ranking. <jats:styled-content style="fixed-case">FDA</jats:styled-content> also suggests different methods be used to assess similarity for <jats:styled-content style="fixed-case">CQAs</jats:styled-content> from different tiers. For example, equivalence test for <jats:styled-content style="fixed-case">CQAs</jats:styled-content> from Tier 1, quality range approach for <jats:styled-content style="fixed-case">CQAs</jats:styled-content> from Tier 2, and descriptive raw data and graphical comparison for <jats:styled-content style="fixed-case">CQAs</jats:styled-content> from Tier 3. In this article, controversial issues regarding the <jats:styled-content style="fixed-case">FDA</jats:styled-content>’s recommended approaches are discussed followed by alternative methods for assessment of similarity for <jats:styled-content style="fixed-case">CQAs</jats:styled-content> from Tier 1. <jats:italic>WIREs Comput Stat</jats:italic> 2017, 9:e1407. doi: 10.1002/wics.1407</jats:p><jats:p>This article is categorized under:
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<jats:list-item><jats:p>Applications of Computational Statistics > Clinical Trials</jats:p></jats:list-item>
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