生物等效性和生物利用度杂志

抽象的

Quantitative Evaluation of Bioequivalence/Biosimilarity

Shein-Chung Chow

As more biologic products are going off patent protection, the development of follow-on biologics (biosimilars) products has received much attention from both biotechnology industry and the regulatory agencies. Unlike traditional small-molecule (chemical) drug products, the development of biologic products is very different and variable with respect to the manufacturing process and environment. 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, an overview of current criteria, study design, and statistical methods for quantitative evaluation of bioequivalence for the traditional small molecule generic drug productsand biosimilarity for biosimilars products is provided. In addition, a general approach for development of a biosimilarity index based on the concept of reproducibility probability for quantitative evaluation of bioequivalence/biosimilarity is proposed. Some scientific factors and practical issues are also discussed.