Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Faculty Publications Article Faculty Publications -Articles Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Monisha, B.; Valarmathi, R. Title A name given to the resource Regulatory data protection for global economy of biopharmaceuticals: comparative legal analysis with focus on innovative biopharma in India Date A point or period of time associated with an event in the lifecycle of the resource 01-01-2025 Source A related resource from which the described resource is derived International Journal of Trade and Global Markets;Volume;21;Issue;3;pp.319-353 Identifier An unambiguous reference to the resource within a given context <a href="https://doi.org/10.1504/IJTGM.2025.148046" target="_blank" rel="noreferrer noopener">https://doi.org/10.1504/IJTGM.2025.148046</a> <br /><br /><a href="https://www.scopus.com/pages/publications/105013381875?origin=resultslist" target="_blank" rel="noreferrer noopener">https://www.scopus.com/pages/publications/105013381875?origin=resultslist</a> Coverage The spatial or temporal topic of the resource, the spatial applicability of the resource, or the jurisdiction under which the resource is relevant Monisha B., School of Law, Christ (Deemed to be University), Karnataka, Bengaluru, 560029, India; Valarmathi R., School of Law, Christ (Deemed to be University), Karnataka, Bengaluru, 560029, India Description An account of the resource This provides a new global economy of biopharmaceuticals with an exclusive right over clinical data, meaning that no other person or persons may use them for a specified period. This study, therefore, offers a critical analysis of complementary protection granted to biopharmaceuticals by patents and regulatory data protection (RDP) globally with respect to innovation, competition, and access to medicines. This study probes the effectiveness and the challenge RDP is making using statistical analysis, financial modelling, and comparative analysis of the regulatory framework in Central Drugs Standard Control Organization (CDSCO), Food and Drug Administration (FDA), and Emergency Market Authorization (EMA). The justification for this combination is that RDP fosters innovation due to the protection of clinical trial investments, which provides a drive for the introduction of innovative biologics but does not inhibit the launch of biosimilars. With RDP, though they are very different in what they do, patents have created an enabling environment to make sustainable innovation in biopharmaceuticals accessible. International regulatory hurdles have to emerge so that a balance that advances both innovation and affordability becomes the norm within biopharma. Copyright 2025 Inderscience Enterprises Ltd. Subject The topic of the resource access to medicine; clinical trial investments; global economy of biopharmaceuticals; patent law; RDP; regulatory data protection; sustainable development goal Publisher An entity responsible for making the resource available Inderscience Publishers Relation A related resource ISSN: 17427541; Language A language of the resource English Type The nature or genre of the resource Article Rights Information about rights held in and over the resource Restricted Access; Hardcopy may be available in the library Format The file format, physical medium, or dimensions of the resource online