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Primary and Higher-Order Structural Characterization Strategy for Biosimilarity Assessment

May 23, 2016
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This article addresses some issues involved in meeting regulatory characterization expectations for biosimilars by answering the following questions: What regulatory guidelines are associated with structural characterization and comparability/biosimilarity testing? What complicates the characterization of complex (glyco)protein products? When is analytical characterization required? And which techniques (old and new) are suitable for this application?

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