This randomised, double-blind, euglycemic clamp study was conducted in T1DM patients to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Biocon’s insulin glargine compared to the originator product, Lantus (insulin glargine).

Insulin glargine is a long acting analogue of human insulin for the treatment of type 1 and type 2 diabetes mellitus patients. It differs from insulin with respect to three amino acids such that the amino acid asparagine at position A21 is replaced by glycine and two arginine amino acids are added to the c-terminal of the B-chain.

The cross over trial compared 100 IU/mL of Lantus and Biocon’s insulin glargine to establish PK and PD equivalence in T1DM patients. The primary endpoints for PK (Insulin-AUC and Insulin-C_max) and PD (Glucose Infusion Rate GIR_max and GIR-AUC) met the pre-specified equivalence margins. Multiple secondary endpoints for PK and PD were also met.

The trial met all its primary and secondary endpoints, thus indicating that Biocon’s insulin glargine is equivalent to the originator product in terms of PK and PD. The company intends to use these results, along with extensive physicochemical and biological characterisation data to start its phase III programme in the US and EU, which is aimed at demonstrating comparative safety, efficacy and immunogenicity in diabetes mellitus patients.

The announcement is good news for the India-based biosimilars major, which was recently subject to the breakdown of its US$200 million deal with pharma giant Pfizer for biosimilar versions of insulin and insulin analogues (recombinant human insulin, aspart, glargine and lispro) [1].

The future looks bright for Biocon’s biosimilar insulin products. Sanofi’s worldwide sales of Lantus during 2011 exceeded Euros 3.9 billion. Diabetes is a growing market–with the WHO reporting that in 2012 one in 10 adults has diabetes and research from the 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. Pfizer and Biocon’s biosimilar insulin deal is off [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Aug 3]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-and-Biocon-s-biosimilar-insulin-deal-is-off