Statistical methods for assessing interchangeability of biosimilars.
Unlike traditional small molecule (chemical) drug products, the development of biologic products is very different and variable with respect to the manufacturing process and environmental factors such as light and temperature. The complexity and heterogeneity of the molecular structure, complicated manufacturing process, different analytical methods, and possibility of severe immunogenicity reactions make quantitative evaluation of follow-on biologics a great challenge to both scientific community and regulatory agencies. In this article, we propose a general approach for development of a biosimilarity index based on the concept of reproducibility probability for quantitative evaluation of biosimilarity and interchangeability. The proposed method is robust regardless the biosimilarity criteria used and/or study design employed.
Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, U.S.A.
Shein-Chung
SC
Chow
Lan-Yan
LY
Yang
Aijing
A
Starr
Shih-Ting
ST
Chiu
D000465:Algorithms; D059451:Biosimilar Pharmaceuticals; D018592:Cross-Over Studies; D057915:Drug Substitution / Q000706:statistics & numerical data*; D006801:Humans; D014481:United States
D059451:Biosimilar Pharmaceuticals