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# Draft Guide for Biosimilar Analytical Similarity Evaluations
- URL: https://www.fdaweb.com/draft-guide-for-biosimilar-analytical-similarity-evaluations/
- Published: 2017-09-22T12:00:00.000Z
- Updated: 2026-09-14T22:52:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139693

*Federal Register* notices: FDA has made available a draft guidance entitled “Statistical Approaches to Evaluate Analytical Similarity.” The document is intended to provide advice on evaluating analytical similarity to sponsors interested in developing biosimilar products. Specifically, it describes the type of information biosimilars should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in developing an analytical similarity assessment plan for the proposed product, and the statistical approaches recommended for evaluating analytical similarity.