Comparative assessment of immunogenicity of recombinant insulin Aspart from BioGenomics and its originator NovoRapid ® in adult patients with type 2 diabetes mellitus

ConclusionsThe immunogenicity assessment based on the overall incidence of patients positive for AIA, changes in incidence of patients positive for AIA post-baseline, TEAR rates and absence of neutralizing antibodies, were found to be apparently similar and comparable in both the treatment groups (BGL –ASP and RMP). We conclude from our studies that the immunogenicity of BGL–ASP is similar and comparable to RMP and the observed immunogenicity in terms of anti-insulin Aspart antibody levels had no impact on the biological activity of insulin.
Source: Journal of Endocrinological Investigation - Category: Endocrinology Source Type: research