Draft Guidance for Industry on Statistical Approaches to Evaluate Analytical Similarity
Statistical Approaches to Evaluate Analytical Similarity is a draft guidance for industry intended to assist sponsors in demonstrating that a proposed biosimilar is “highly similar” to a U.S.-licensed reference product, through an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 Specifically, the draft guidance describes: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.