Equivalence of Biosimilarity in Pharmacokinetic and Pharmacodynamic Properties of Recombinant Human Insulin Aspart.

Insulin aspart, a rapid-acting analog, achieves faster subcutaneous absorption than regular insulin. This study aimed to demonstrate equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of Recombinant Human Insulin Aspart from BioGenomics Limited (as test) and Novo-Nordisk (as reference) in healthy adult males. This was a double-blind, randomized, cross-over study, assessing PK and PD parameters under fasting conditions.

Efficacy, safety, and immunogenicity of recombinant insulin aspart (BioGenomics Limited) and NovoRapid (Novo Nordisk) in adults with type 2 diabetes mellitus: a randomized, open-label, multicenter, phase-3 study.

Background And Purpose: To compare the efficacy, safety, and immunogenicity of recombinant insulin aspart 100 U/mL manufactured by BioGenomics Limited (BGL-ASP) with innovator NovoRapid in type 2 diabetes mellitus patients (T2 DM).

Experimental Approach: This was a multicenter, open-label, randomized, parallel-group study in T2 DM patients, on premix human insulin therapy ± oral anti-diabetics. Besides self-monitored plasma glucose, fasting and post-prandial plasma glucose (FPG and PPG) were tested at baseline, week 12, and week 24.

Comparative physicochemical and structural characterisation studies establish high biosimilarity between BGL-ASP and reference insulin aspart.

Biosimilar insulin analogues are increasing market access for diabetic patients globally. Scientific establishment of biosimilarity is cornerstone of this key change in the medical landscape. BGL-ASP is a biosimilar insulin aspart developed by BioGenomics Limited, India.

In Vitro Biological Characterization of Recombinant Insulin Aspart from Biogenomics and Originator Insulin Aspart.

Background: Bioassays are used to identify the pharmacological activity of new or chemically unknown compounds, as well as their undesirable effect, including toxicity. Biological assays are also required to ensure the quality, safety, and efficacy of recombinant biologics to confirm its biosimilarity to its originator. In the present study, analytical similarity between the biosimilar and its innovator is established by in vitro bioassays.