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Table 1 Definitions of Percent Specific Binding Used in Radioimmunoprecipitation Assays

From: Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies

Assay

Percent specific binding definition

MYL-1501D

Total ADA

%B/T (no inhibitor) − %B/T (excess MYL-1501D)

Insulin cross-reactive ADA

%B/T (no inhibitor) − %B/T (excess insulin)

Drug-specific ADA

%B/T (excess IGlar) − %B/T (excess MYL-1501D)

IGlar

Total ADA

%B/T (no inhibitor) − %B/T (excess reference insulin glargine)

Insulin cross-reactive ADA

%B/T (no inhibitor) − %B/T (excess insulin)

Drug-specific ADA

%B/T (excess MYL-1501D) − %B/T (excess IGlar)

  1. ADA antidrug antibodies, %B/T percentage of bound to total reactivity, IGlar insulin glargine