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Analytical consideration in demonstrating similarity for biosimilars

05:09 EDT 13 Jul 2018 | Generics and Biosimilars Initiative

According to the US Food and Drug Administration (FDA) guideline on ‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product’ [1], ‘FDA expects that first, a sponsor will extensively characterize the proposed product and the reference product with state‐of‐the‐art technology, because extensive characterization of both products serves as the foundation for a demonstration of biosimilarity’ [2].

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