相似性评价-FDA_equivalenttest.pdfVIP

Statistical Approaches for Analytical Biosimilarity Evaluation Xiaoyu (Cassie) Dong CDER/OTS/OB/DB 6 Collaborate with Drs. Yi Tsong and Meiyu Shen Disclaimer: This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies. 1 Outline I. Overview of 3-Tiered Approach II. Tier 1 - Statistical Equivalence Testing III. An Example of Tier 1 Statistical Equivalence Testing IV. Remarks 2 I. Overview of 3-Tier Approach Definition of Biosimilar or Biosimilarity:  that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and  there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. Biosimilar ≠Biosame ≠ Biobetter Reference: Leah Christl, Biosimilar AC Webinar 3 I. Overview of 3-Tier Approach (Cont’d) • A stepwise approach to assess similarity: Additional Clinical Clin. Pharm Foundation Non-clinical Analytical Totality-of-the-Evidence 4 I. Overview of 3-Tier Approach (Cont’d) • Analytical similarity study: Characterize the proposed biosimilar and its reference product; Tests for a number of quality attributes (QA);