ABSTRACT
Since the first approval of a biosimilar in 2015, there are about 26 biosimilar products approved in the US by 2019, and for the EU, which has a long history of approval of biosimilar products with its first approval in 2006, about 60 biosimilars have been approved for 16 reference products by EMA. In the development of those biosimilar products, one of the key objectives is to show no clinically meaningful differences between the biosimilar product under development and the reference product in terms of safety, purity, and potency. To achieve such an objective, statistical assessment is considered to be the foundation to demonstrate both analytical and clinical similarity through the stepwise approach for demonstrating analytical similarity, interchangeability, selection of endpoints, and determination of similarity margins. This chapter illustrates how such statistical assessment was conducted in real cases by reviewing four biosimilar products already approved: Remsima® , Mvasi®, Truxima®, and Amjevita®. Most of the information and data presented in this chapter for each of the four products are based on regulatory guidelines, published literature, and review documents by major health authorities including FDA and EMA associated with the selected biosimilar products.
