Biocon has received positive results from the global phase III study for its Recombinant Human Insulin Insugen, in type 1 diabetes mellitus (T1DM) patients as it demonstrated comparable safety and efficacy with the innovator product of Novo Nordisk.

This multi-centre, randomized study was conducted in nearly 300 T1DM patients, to compare efficacy, safety and immunogenicity of Biocon’s regular human insulin known as Insugen R and Isophane human Insulin referred to as Insugen N against the innovator products Actrapid and Insulatard which are  registered brands of Denmark-based Novo Nordisk. The trial met its efficacy end-point by demonstrating non-inferiority in HbA1c endpoint at six months. Immunogenicity and safety as evaluated by hypoglycemic events at the six month time point were also similar.

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.

Data from this ongoing study along with extensive physico-chemical & 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.

“The positive outcome of this global phase III study is a significant milestone in our global insulins development programme and will enable regulatory approvals of our recombinant human insulin products across developed and emerging markets. Human insulin is a widely accepted component of insulin therapy for diabetes patients and Biocon’s human insulin, will present an affordable alternative to the patients worldwide. These data along with the recent PK-PD data for our insulin glargine (BASALOG) demonstrate our commitment to pursue our global insulins strategy and deliver affordable therapy to the patients, said Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited.

“This data along with extensive characterization and PK-PD data generated to date with Biocon’s regular and isophane insulin demonstrate comparability with the innovator products”, said Dr Abhijit Barve, president, R&D, Biocon. “This was our first global study for rh-Insulin and we are pleased with the outcome. These data and our recent positive PK-PD data for Biosimilar Glargine enable us to pursue our global development strategy for Biosimilar Insulins.”

Insugen R is short-acting human insulin and offers post meal control of glucose while Insugen N is long-acting human insulin and offers basal control of glucose levels. Human recombinant insulin is used as a basal-bolus regimen or pump regimen and is most widely used by Type 1 and Type 2 diabetics in most parts of the world. Biocon’s Insugen is currently marketed in various countries and this data will reinforce the confidence of physicians and diabetes care providers in Insugen and other products in the insulin portfolio. We will be aggressively taking these products to the EU region,  said Shaw at the Q2 corporate results.