Biocon, a Rs. 2,000 crore plus premier biotechnology company, has announced 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 Biocon’s Insulin Glargine against the innovator product (Lantus). The trial met all its primary and secondary endpoints.

These 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 programme in the US and EU aimed at demonstrating comparative safety, efficacy and immunogenicity in diabetes mellitus patients.

“This study clearly demonstrates that Biocon’s Insulin Glargine is bioequivalent to Lantus, so that both insulins will have the same effect when used in identical doses”, said Dr Tim Heise, CEO Science & Administration of Profil in Neuss, Germany, and Principal Investigator of the study. “The study had a robust design, was conducted under the international standards of ICH/GCP (International Conference of Harmonization/Good Clinical Practice) and used an automated euglycemic glucose clamp technique which is the gold standard for assessment of the pharmacodynamic properties of insulin preparations. Biocon’s Insulin Glargine and Lantus were very well tolerated; without any serious adverse event observed during the four month study period. I am very confident that based on these data, regulators will accept the pharamcokinetic and pharmacodynamic biosimilarity of Biocon’s Insulin Glargine and Lantus.”

Expressing her satisfaction with the clinical development progress Kiran Mazumdar-Shaw, chairman & managing director, Biocon said, “Insulin Glargine is a key product in our growing portfolio of biosimilar insulins. The successful outcome of this critical phase 1 study demonstrates our strong commitment towards developing high quality biosimilars and paves the way for the phase 3 programme of Biosimilar Insulin Glargine that will enable regulatory approvals of our product across developed and emerging markets. These data will further increase the confidence of physicians prescribing Basalog and contribute to our vision to have market leadership in biosimilar products.”

Biocon intends on conducting the phase 3 global programme using internal resources and will be engaging with several potential regional and global partners to ensure affordable innovation is accessible to all patients across the globe.

This cross over trial conducted in Germany, comparing 100 IU/ml of Lantus and Biocon’s Insulin Glargine to establish PK and PD equivalence was conducted in T1DM patients. The study was sufficiently powered to establish bioequivalence. The primary endpoints for PK (Insulin-AUC and Insulin-Cmax) and PD (Glucose Infusion Rate GIRmax and GIR-AUC) met the pre-specified equivalence margins. Multiple secondary endpoints for PK and PD were also met.