Positive results from phase III study with biosimilar human insulin

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Positive results from phase III study with biosimilar human insulin

Biosimilares/Investigación | Posted 16/11/2012 0 Post your comment

One of Asia’s leading biotechnology companies, Biocon, announced on 31 October 2012 positive results from its global phase III study for its recombinant human insulin (Insugen). The study, which was carried out in type 1 diabetes mellitus (T1DM) patients, demonstrated comparable safety and efficacy compared to the originator product.

The multi-centre, randomized study was conducted in nearly 300, T1DM patients, and compared efficacy, safety and immunogenicity of Biocon’s regular human Insulin (Insugen R) and isophane human Insulin (Insugen N) against Novo Nordisk’s originator products, Actrapid and Insulatard. The trial met its efficacy endpoint by demonstrating non-inferiority in HbA1c endpoint at six months. Immunogenicity and safety as evaluated by hypoglycaemic events at the six-month time point were also similar.

Insugen R is short-acting human insulin, which offers post-meal control of glucose while Insugen N is long-acting human insulin, which 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, e.g. China and India.

The second part of the study, which aims to demonstrate additional safety and immunogenicity over one year, is ongoing and is expected to be completed by 2013 with the final results expected in 2014.

Biocon expects data from this ongoing study, along with extensive physicochemical and biological characterization; and pharmacokinetic and pharmacodynamic data generated to date comparing Insugen-R and Insugen-N with the originator products, to enable the Indian biotech to submit a robust dossier for marketing authorization in EU and other global markets.

The future looks bright for Biocon’s biosimilar insulin products. The company also announced in July 2012 positive results from a phase I comparative study conducted in Germany of its biosimilar insulin glargine in type 1 diabetes mellitus (T1DM) patients [1].

Diabetes is a growing market, with WHO reporting that in 2012 one in 10 adults has diabetes and research from UK showing a 74% rise in new cases of diabetes between 1997 and 2003.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Positive results from phase I study with biosimilar insulin glargine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 16]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-from-phase-I-study-with-biosimilar-insulin-glargine

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Source: BBC, WHO