Biocon, Indian biotechnology company, announced that the global Phase III study for its Recombinant Human Insulin, in Type 1 diabetes mellitus patients, demonstrates comparable safety and efficacy with the innovator product.
The multi-center, randomized study was conducted in nearly 300, Type 1 diabetes mellitus (T1DM) patients, to compare efficacy, safety and immunogenicity of Biocon’s Regular human Insulin (Insugen R) and Isophane human Insulin (Insugen N) against the innovator products (Actrapid and Insulatard) sourced from Europe. The trial met its efficacy end-point by demonstrating non-inferiority in HbA1c endpoint at 6 months. Immunogenicity and safety as evaluated by hypoglycemic events at the 6 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 2014.
Data from this ongoing study along with extensive physico-chemical and biological characterization and PK-PD (pharmacokinetic and pharmaco-dynamic) data generated to date comparing Insugen-R and Insugen-N with the innovator products will enable Biocon to submit a robust dossier for marketing authorization in EU and other global markets.
Commenting on these results, Ms. Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon said, “The positive outcome of this global phase 3 study is a significant milestone in our global insulins development program 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.”
“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 Research and Development of 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.”
Source: Biocon press release