ABSTRACT
As indicated earlier, the U.S. BPCI Act defines a biosimilar product as a product that is highly similar to an innovative biological product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences in terms of safety, purity, and potency. Thus, safety is a great concern when assessing biosimilarity of biosimilar products. Since the issue of immunogenicity is one of the fundamental differences between small-molecule drug products and biological products, when to conduct immunogenicity testing for the evaluation of immunotoxicity has become an important issue in biosimilar studies.
