Comparability is a well-established scientific concept that is pivotal to biological product realisation. It successfully enables product development and lifecycle management of existing products and the development of biosimilars.
In the more recent past, the setting of comparability/similarity criteria and the role statistics therein received more and more attention. After an initial draft in 2017, EMA published the final version of the reflection paper on that topic in July 2021. It is accessible online via - https://www.ema.europa.eu/documents/scientific-guideline/reflection-paper-statistical-methodology-comparative-assessment-quality-attributes-drug-development_en.pdf.
In this session, we will focus on the comparative assessment of quality attributes, discuss the reflection paper and how it will impact future comparability exercises for manufacturing changes and biosimilars. We will discuss what is necessary to achieve robust quality packages to demonstrate comparability and how statistical evaluations can improve decision making by providing a better understanding of similarity criteria. More specifically, we want to improve our understanding of:
• How to set pre-defined, clear and rational criteria for comparability. • How a better understanding of the statistical performance (operating characteristics) supports the letting of meaningful criteria and how it may impact comparability packages. • The relevance of product & process understanding and the control strategy as context for statistical evaluations. • To which extent new concepts can contribute to efficient and scientifically meaningful approaches for comparability in a global environment.