Draft Guidance for Industry on Statistical Approaches to Evaluate Analytical Similarity

Statistical Approaches to Evaluate Analytical Similarity is a draft guidance for industry intended to assist sponsors in demonstrating that a proposed biosimilar is “highly similar” to a U.S.-licensed reference product, through an evaluation of the analytical similarity of the proposed biosimilar and reference product. Specifically, the draft guidance describes: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.
  • The statistical approaches recommended for evaluating analytical similarity.

Statistical Approaches to Evaluate Analytical Similarity serves as a companion document to the guidance for industry titled Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product, which was finalized in April 2015.

The full document is available on the FDA website.