Today, the Food and Drug Administration (FDA) released the draft guidance for industry “Statistical Approaches to Evaluate Analytical Similarity.” This draft guidance provides advice on the evaluation of analytical similarity to sponsors interested in developing biosimilar products. The evaluation described in this draft guidanceis performed to support the demonstration that a proposed biosimilar product is highly similar to a reference product. The guidance describes the type of information a sponsor of a proposed biosimilar product should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan for the proposed biosimilar, and the statistical approaches recommended for evaluating analytical similarity. This guidance is one in a series of guidance documents that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). It serves as a companion document to the guidance for industry Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product. For information on how to submit comments on this draft guidance, see the Notice of Availability.
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