Establishment of reference standards in biosimilar studies.

When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus, it is important to first establish a reference standard while assessing biosimilarity between a biosimilar product and the reference product. In this paper, reference standard is established through the biosimilarity index approach based on a reference-replicated study (or R-R study), in which the reference product is compared with itself under various scenarios. The reference standard can then be used for assessing the degree of similarity between the test and reference drugs in biosimilar studies.