an application for regulatory approval of biosimilar products. Unlike small molecule drug products, biosimilars are\nnot exact copies of their brand-name counterpart, and they are usually very sensitive to changes in environmental\nfactors and have greater variabilities due to their complexity and sensitivity to variation in manufacturing processes.\nFacing these challenges, a biosimilarity index based on reproducibility probability is proposed to assess biosimilarity.\nIn this article, we have demonstrated how to assess biosimilarity between the test and reference product in relative\nto a reference standard that is established in a study where reference product is compared with itself. Biosimilairty\nindex approach is robust against biosimilarity criteria and has the advantage of allowing the assessment of the\ndegree of similarity.
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