Biocon, Asia’s premier biotechnology company, has reported positive results from a Phase 1 comparative study conducted in Germany of its Biosimilar Insulin Glargine in Type 1 Diabetes Mellitus (T1DM) patients.
This randomized, double-blind, euglycemic clamp study was conducted in T1DM patients to evaluate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of the company’s insulin Glargine against the innovator product (Lantus). The trial met all its primary and secondary endpoints.
The encouraging results indicate that Biocon’s insulin Glargine is equivalent to the innovator product in terms of PK and PD. These robust clinical data along with extensive physicochemical and biological characterization data generated to date between Biocon’s Insulin Glargine and the innovator product will enable Biocon to start its Phase 3 program in the US and EU aimed at demonstrating comparative safety, efficacy and immunogenicity in diabetes mellitus patients.
Biocon produces anti-diabetic agents like Acarbose, Pioglitazone, Repaglinides and Rosiglitazone. In the biological segment it produces Insulin, Erythropoietin (EPO), Filgrastim (GCSF), Streptokinase and Monoclonal Antibodies.
