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Comparative physicochemical and structural characterisation studies establish high biosimilarity between BGL-ASP and
Nikhil S Ghade1, Damodar K Thappa2, Jeseena Lona2
1BioGenomics Limited, Thane, Maharashtra, 400610, India. nikhil.ghade@biogenomics.co.in.
Scientific Reports
|February 20, 2024
Summary
Biosimilar insulin aspart (BGL-ASP) demonstrates high similarity to the reference product in structure, purity, and function. Clinical trials confirm its comparable safety and efficacy, offering an economical alternative for diabetes mellitus treatment.
Area of Science:
- Biochemistry
- Pharmacology
- Biotechnology
Background:
- Biosimilar insulin analogues are expanding global access for diabetes patients.
- Establishing biosimilarity is crucial for regulatory approval and market integration.
- BGL-ASP is a biosimilar insulin aspart developed by BioGenomics Limited.
Purpose of the Study:
- To establish the scientific basis for biosimilarity of BGL-ASP with the reference insulin aspart.
- To evaluate the critical quality attributes (CQAs), safety, efficacy, and immunogenicity of BGL-ASP.
- To demonstrate BGL-ASP as a comparable and economical alternative for diabetes treatment.
Main Methods:
- Characterization of CQAs using orthogonal analytical tools, focusing on structure, purity, and functionality.
- High-performance liquid chromatography (HPLC) for assay and impurity profiling.
- Clinical trials adhering to ICH and EMA guidelines to assess safety, efficacy, and immunogenicity.
Main Results:
- BGL-ASP exhibits high similarity in primary, secondary, tertiary, and quaternary protein structures compared to the reference product.
- HPLC analysis shows comparable assay content and product-related impurities.
- Clinical trials confirm comparable safety, efficacy, and immunogenicity, meeting regulatory standards.
Conclusions:
- BGL-ASP is highly similar to reference insulin aspart in structural, physicochemical, and biological properties.
- The study confirms the safety and efficacy of BGL-ASP for treating diabetes mellitus.
- BGL-ASP presents a potential economical alternative medicinal treatment for patients with diabetes mellitus.
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