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Regulatory Requirements for Interchangeable Biosimilar Designation.

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Title: Regulatory Requirements for Interchangeable Biosimilar Designation.
Authors: Samy PJ; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Mouslim MC; The Hilltop Institute, University of Maryland, Baltimore County, 1000, Hilltop Circle, Baltimore, MD, USA. mmousli1@umbc.edu.; Department of Health Management and Policy, University of Michigan, Ann Arbor, MI, USA. mmousli1@umbc.edu., Bennett CL; College of Pharmacy, University of South Carolina, Columbia, SC, USA., Trujillo AJ; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2026 Mar; Vol. 60 (2), pp. 346-348. Date of Electronic Publication: 2025 Nov 16.
Publication Type: Journal Article
Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE; In Process
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Samy+PJ%22">Samy PJ</searchLink>; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.<br /><searchLink fieldCode="AU" term="%22Mouslim+MC%22">Mouslim MC</searchLink>; The Hilltop Institute, University of Maryland, Baltimore County, 1000, Hilltop Circle, Baltimore, MD, USA. mmousli1@umbc.edu.; Department of Health Management and Policy, University of Michigan, Ann Arbor, MI, USA. mmousli1@umbc.edu.<br /><searchLink fieldCode="AU" term="%22Bennett+CL%22">Bennett CL</searchLink>; College of Pharmacy, University of South Carolina, Columbia, SC, USA.<br /><searchLink fieldCode="AU" term="%22Trujillo+AJ%22">Trujillo AJ</searchLink>; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
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  Data: <searchLink fieldCode="JN" term="%22101597411%22">Therapeutic innovation & regulatory science</searchLink> [Ther Innov Regul Sci] 2026 Mar; Vol. 60 (2), pp. 346-348. <i>Date of Electronic Publication: </i>2025 Nov 16.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer+International+Publishing%22">Springer International Publishing </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>101597411 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2168-4804 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2221684790%22">21684790 </searchLink><i>NLM ISO Abbreviation: </i>Ther Innov Regul Sci <i>Subsets: </i>MEDLINE; In Process
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        Value: 10.1007/s43441-025-00897-6
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        Text: English
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      – TitleFull: Regulatory Requirements for Interchangeable Biosimilar Designation.
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              Text: 2026 Mar
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              Y: 2026
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