Biocon, Asia’s premier biotechnology company, has reported positive results from the Global Phase 3 study for its Recombinant Human Insulin (INSUGEN), in Type 1 diabetes mellitus (T1DM) patients, demonstrates comparable safety and efficacy with the innovator product.
This multi-center, randomized study was conducted in nearly 300, T1DM patients, to compare efficacy, safety and immunogenicity of the company’s Regular human insulin (Insugen R) and lsophane human Insulin (Insugen N) against the innovator products (Actrapid and Insulatard) sourced from Europe.
The Part 2 of the study to demonstrate additional safety and immunogenicity over one year is ongoing and is expected to be completed by next year with the final results expected in H1, FY14.
The above data from this ongoing study along with extensive physico-chemical and biological characterization and PK-PD (pharmacokinetic & pharmaco-dynamic) data generated to date comparing Insugen-R & Insugen-N with the innovator products will enable Biocon to submit a robust dossier for marketing authorization in EU and other global markets.
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.
