ABSTRACT
As indicated in the previous chapter, biosimilar products are variable and very sensitive to small changes (or variations) in environmental factors during the manufacturing process. In a biosimilar study, small variability associated with observed response is an indication that the observed difference in response between biosimilar products is not by chance alone and it is reproducible. In addition, small variability is also an indication of good drug characteristics such as stability and quality of the biosimilar product under investigation. Thus, in addition to the comparison of average responses between a biosimilar (test) product and an innovative (reference) product, it is suggested that the variabilities between the test product and the reference product should also be compared when assessing biosimilarity. The comparison of variabilities of responses between biosimilar products provides valuable information regarding the degree of similarity and how similar is considered highly similar in addition to average biosimilarity.
