Skip to main content
Journal cover image

Current Issues in Analytical Similarity Assessment

Publication ,  Journal Article
Chow, SC; Lee, SJ
Published in: Statistics in Biopharmaceutical Research
January 1, 2021

In 2017, Food and Drug Administration (FDA) circulated a draft guidance on analytical similarity assessment to assist the sponsors for providing totality-of-the-evidence in support of the demonstration of biosimilarity between a proposed biosimilar product and an innovative biological product. The guidance was subsequently withdrawn by the FDA due to some major criticisms received from general public. These major criticisms include, but are not limited to, (i) the use of 90% confidence interval (CI) versus 95% CI, (ii) tiered approach for analytical similarity evaluation, and (iii) current practical issues related to analytical similarity assessment. In this article, these major criticisms and issues are discussed. In addition, some recommendations regarding alternative thinking or methods for analytical similarity evaluation are provided.

Duke Scholars

Published In

Statistics in Biopharmaceutical Research

DOI

EISSN

1946-6315

Publication Date

January 1, 2021

Volume

13

Issue

2

Start / End Page

203 / 209

Related Subject Headings

  • 0104 Statistics
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Chow, S. C., & Lee, S. J. (2021). Current Issues in Analytical Similarity Assessment. Statistics in Biopharmaceutical Research, 13(2), 203–209. https://doi.org/10.1080/19466315.2020.1801497
Chow, S. C., and S. J. Lee. “Current Issues in Analytical Similarity Assessment.” Statistics in Biopharmaceutical Research 13, no. 2 (January 1, 2021): 203–9. https://doi.org/10.1080/19466315.2020.1801497.
Chow SC, Lee SJ. Current Issues in Analytical Similarity Assessment. Statistics in Biopharmaceutical Research. 2021 Jan 1;13(2):203–9.
Chow, S. C., and S. J. Lee. “Current Issues in Analytical Similarity Assessment.” Statistics in Biopharmaceutical Research, vol. 13, no. 2, Jan. 2021, pp. 203–09. Scopus, doi:10.1080/19466315.2020.1801497.
Chow SC, Lee SJ. Current Issues in Analytical Similarity Assessment. Statistics in Biopharmaceutical Research. 2021 Jan 1;13(2):203–209.
Journal cover image

Published In

Statistics in Biopharmaceutical Research

DOI

EISSN

1946-6315

Publication Date

January 1, 2021

Volume

13

Issue

2

Start / End Page

203 / 209

Related Subject Headings

  • 0104 Statistics