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@article{185075,
        author = {Narottam Pal and B.Varshitha and C.Pratyusha and Smitha Surajit Das and G.Swapna},
        title = {Analytical Comparability Studies of Biosimilar Insulin Products},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {5},
        pages = {187-192},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=185075},
        abstract = {Background: The increasing global demand for affordable diabetes therapeutics has driven the development of biosimilar insulin products. However, ensuring analytical comparability between biosimilar and reference insulin products remains a critical challenge for regulatory approval and clinical acceptance.
Objective: This study establishes a comprehensive analytical framework for evaluating the comparability of biosimilar human insulin products to their reference standards, incorporating physicochemical, biological, and stability parameters.
Methods: We developed a multi-tiered analytical approach encompassing primary structure analysis (amino acid sequencing, peptide mapping), higher-order structure evaluation (circular dichroism, fluorescence spectroscopy), biological activity assessment (cell-based potency assays), and accelerated stability studies. Five biosimilar insulin products were compared against the reference insulin using this framework.
Results: Our analytical battery demonstrated that 4 out of 5 biosimilar products showed acceptable similarity to the reference insulin across all tested parameters. Key differentiating factors included aggregation profiles, oxidative variants, and thermal stability characteristics. The developed scoring matrix provided quantitative comparability assessment with regulatory alignment.
Conclusions: This comprehensive analytical framework offers a robust methodology for biosimilar insulin evaluation, potentially accelerating regulatory pathways while ensuring patient safety through rigorous quality assessment.},
        keywords = {Biosimilar insulin, analytical comparability, regulatory science, diabetes therapeutics, quality assessment},
        month = {September},
        }