Infliximab Biosimilars in the Age of Personalized Medicine

Jukyung Kang; Karthik Pisupati; Alexander Benet; Brandon T Ruotolo; Steven P Schwendeman; Anna Schwendeman

doi:10.1016/j.tibtech.2018.05.002

Infliximab Biosimilars in the Age of Personalized Medicine

Trends Biotechnol. 2018 Oct;36(10):987-992. doi: 10.1016/j.tibtech.2018.05.002. Epub 2018 May 31.

Authors

Jukyung Kang¹, Karthik Pisupati¹, Alexander Benet¹, Brandon T Ruotolo², Steven P Schwendeman¹, Anna Schwendeman³

Affiliations

¹ Biointerfaces Institute, University of Michigan, 2800 Plymouth Road, Ann Arbor, MI 48109, USA; Department of Pharmaceutical Sciences, University of Michigan, 432 Church Street, Ann Arbor, MI 48109, USA.
² Department of Chemistry, University of Michigan, 930 North University Street, Ann Arbor, Michigan 48109, USA.
³ Biointerfaces Institute, University of Michigan, 2800 Plymouth Road, Ann Arbor, MI 48109, USA; Department of Pharmaceutical Sciences, University of Michigan, 432 Church Street, Ann Arbor, MI 48109, USA. Electronic address: [email protected].

PMID: 29861288
DOI: 10.1016/j.tibtech.2018.05.002

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.

Keywords: REMICADE; antibody-dependent cell-mediated cytotoxicity; biosimilar; biosimilar interchangeability; glycosylation; infliximab.

Publication types

Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Review

MeSH terms

Antirheumatic Agents / administration & dosage*
Antirheumatic Agents / chemistry
Biosimilar Pharmaceuticals / administration & dosage*
Biosimilar Pharmaceuticals / chemistry
Gastrointestinal Agents / administration & dosage*
Gastrointestinal Agents / chemistry
Inflammatory Bowel Diseases / drug therapy
Infliximab / administration & dosage*
Infliximab / chemistry
Polymorphism, Genetic
Precision Medicine / methods*
Receptors, IgG / genetics
Rheumatic Fever / drug therapy

Substances

Antirheumatic Agents
Biosimilar Pharmaceuticals
FCGR3A protein, human
Gastrointestinal Agents
Receptors, IgG
Infliximab