Infliximab Biosimilars in the Age of Personalized Medicine. Issue 10 (October 2018)

• Record Type: Journal Article
• Authors: Kang, Jukyung; Pisupati, Karthik; Benet, Alexander; Ruotolo, Brandon T.; Schwendeman, Steven P.; Schwendeman, Anna
• Is Part Of: Trends in biotechnology. Volume 36:Issue 10(2018)
• Page Start: 987
• Page End: 992
• Publication Date: 2018-10
• Subjects: antibody-dependent cell-mediated cytotoxicity -- biosimilar -- biosimilar interchangeability -- glycosylation -- infliximab -- REMICADE; Biotechnology -- Periodicals; Biochemical engineering -- Periodicals; Genetic engineering -- Periodicals; Industrial microbiology -- Periodicals; 660.605
• DOI: 10.1016/j.tibtech.2018.05.002
• Languages: English
• ISSNs: 0167-7799

Abstract

Abstract : Structural and functional differences between REMICADE and its two FDA-approved biosimilars appear to have clinical implications. We suggest a personalized biosimilar substitution approach based on prescribed indication, biosimilar afucosylation level, and a patient's FCGR3A polymorphism. We also advocate for establishing glycosylation variation limits for biosimilar approvals.