Immunogenicity assay supporting clinical development of RGB-19, a proposed biosimilar to RoActemra®.
The aim of the work was to develop and validate an anti-drug antibody (ADA) assay for RGB-19, a proposed biosimilar to tocilizumab, capable of detecting anti-tocilizumab antibodies in the presence of high concentrations of soluble IL-6 receptor (sIL-6R), the drug's pharmacologic…