Establishment of reference standards in biosimilar studies.

TitleEstablishment of reference standards in biosimilar studies.
Publication TypeJournal Article
Year of Publication2013
AuthorsZhang, Aijing, Jung-Ying Tzeng, and Shein-Chung Chow
JournalGaBI J
Date Published2013 Jul 31

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.

Alternate JournalGaBI J
Original PublicationEstablishment of reference standards in biosimilar studies.
PubMed ID24734164
PubMed Central IDPMC3984577
Grant ListP01 CA142538 / CA / NCI NIH HHS / United States