Keywords: analytical similarity , biosimilar submissions
The Food and Drug Administration in the United States (US FDA) issued the draft guidance for industry--Statistical Approaches to Evaluate Analytical Similarity in September 2017. This guidance is intended to provide advice on the evaluation of analytical similarity to sponsors interested in developing biosimilar products for licensure under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). Biosimilars are a new class of medical products; the development paradigm of biosimilars differs from “standalone” biological development and from other abbreviated licensure pathway products such as 505(j) and 505(b)(2) products. A biosimilar must be shown, among other things, to be highly similar to the reference product notwithstanding minor differences in clinically inactive components. Since 2014, there have been more than 20 BLA biosimilars submitted to the US FDA. At least nine Biosimilar BLAs have been approved. We can discuss the statistical challenges and opportunities concerning biosimilar development. We can also discuss how to plan the analytical similarity studies.