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@article{204628,
        author = {A Padmaja},
        title = {Comparative Analysis of Biosimilar Regulatory Frameworks: A Study of USFDA, EMA and CDSCO Approval Pathways},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {3213-3216},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=204628},
        abstract = {Biosimilars have emerged as cost-effective alternatives to innovator biologics, offering significant opportunities to improve patient access to advanced therapies. Due to the inherent complexity of biological products, biosimilars require specialized regulatory pathways distinct from those used for conventional generic medicines. Regulatory authorities including the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Central Drugs Standard Control Organization (CDSCO) have established comprehensive frameworks to ensure biosimilar quality, safety, and efficacy. This study presents a comparative analysis of biosimilar regulatory frameworks implemented by these major agencies. The research evaluates legal frameworks, approval pathways, analytical requirements, clinical studies, pharmacovigilance obligations, interchangeability provisions, and extrapolation principles. A qualitative and descriptive methodology was employed using regulatory guidelines, scientific publications, and official agency documents. The findings indicate that all agencies utilize a stepwise approach based on comparability principles, although differences exist in interchangeability requirements, clinical evidence expectations, and post-marketing surveillance obligations. Harmonization of regulatory standards may further facilitate global biosimilar development and improve healthcare accessibility.},
        keywords = {Biosimilars, Regulatory Affairs, USFDA, EMA, CDSCO, Comparability Exercise, Totality of Evidence, Pharmacovigilance, Biologics.},
        month = {June},
        }