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@article{202098,
        author = {MORUPURI VENKATESH},
        title = {REGULATORY FRAMEWORKS FOR BIOSIMILARS: A COMPARATIVE STUDY OF USFDA, EMA AND CDSCO GUIDELINES},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {12},
        pages = {5971-5974},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=202098},
        abstract = {Biosimilars have emerged as one of the most significant advancements in the pharmaceutical industry by offering cost-effective alternatives to highly expensive biological medicines. Biological products have transformed the treatment of chronic diseases such as cancer, autoimmune disorders, diabetes, rheumatoid arthritis, and various rare disorders. However, the high manufacturing cost, complex production procedures, and stringent regulatory requirements associated with biologics often limit patient accessibility. Biosimilars provide an opportunity to improve access to life-saving therapies by introducing lower-cost alternatives after patent expiration of innovator biologics.
Unlike conventional generic drugs, biosimilars are not exact copies of reference biologic products because they are derived from living organisms and are highly sensitive to manufacturing variations. Even minor changes in production processes may significantly affect product safety, efficacy, purity, and immunogenicity. Therefore, biosimilars require specialized regulatory pathways to demonstrate similarity with reference products through comprehensive analytical, non-clinical, and clinical evaluations.
The present study focuses on a comparative analysis of biosimilar regulatory frameworks established by the U.S. Food and Drug Administration, European Medicines Agency, and Central Drugs Standard Control Organization. The study evaluates regulatory pathways, approval requirements, analytical comparability, clinical studies, interchangeability, extrapolation of indications, and pharmacovigilance requirements.
A descriptive comparative research methodology was adopted by reviewing official regulatory guidelines, scientific journals, and published regulatory literature. The findings reveal that although all three regulatory agencies share common scientific principles, they differ in approval pathways, data requirements, substitution policies, and post-marketing surveillance expectations. The study concludes that global regulatory harmonization is essential for accelerating biosimilar approvals and improving worldwide healthcare accessibility.},
        keywords = {Biosimilars, Regulatory Affairs, USFDA, EMA, CDSCO, Biologics, Pharmacovigilance, Interchangeability},
        month = {May},
        }