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Biological and nonbiological complex drugs for multiple sclerosis in Latin America: Regulations and risk management

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dc.contributor.author Carrá, A.
dc.contributor.author Macías Islas, M.A.
dc.contributor.author Tarulla, A.
dc.contributor.author Bichuetti, D.B.
dc.contributor.author Finkelsztejn, A.
dc.contributor.author Dadalti Fragoso, Y.
dc.contributor.author Árcega-Revilla, R.
dc.contributor.author Cárcamo Rodríguez, C.
dc.contributor.author Durán, J.C.
dc.contributor.author García Bonitto, J.
dc.contributor.author León, R.
dc.contributor.author Oehninger Gatti, C.
dc.contributor.author Orozco, G.
dc.contributor.author Vizcarra Escobar, D.
dc.date.accessioned 2019-02-22T14:55:51Z
dc.date.available 2019-02-22T14:55:51Z
dc.date.issued 2015
dc.identifier.uri https://hdl.handle.net/20.500.12866/5803
dc.description.abstract Biological drugs and nonbiological complex drugs with expired patents are followed by biosimilars and follow-on drugs that are supposedly similar and comparable with the reference product in terms of quality, safety and efficacy. Unlike simple molecules that can be copied and reproduced, biosimilars and follow-on complex drugs are heterogeneous and need specific regulations from health and pharmacovigilance agencies. A panel of 14 Latin American experts on multiple sclerosis from nine different countries met to discuss the recommendations regarding biosimilars and follow-on complex drugs for treating multiple sclerosis. Specific measures relating to manufacturing, therapeutic equivalence assessment and pharmacovigilance reports need to be implemented before commercialization. Physical, chemical, biological and immunogenic characterizations of the new product need to be available before clinical trials start. The new product must maintain the same immunogenicity as the original. Automatic substitution of biological and complex drugs poses unacceptable risks to the patient. en_US
dc.language.iso eng
dc.publisher Taylor & Francis
dc.relation.ispartof urn:issn:1744-8360
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Humans en_US
dc.subject Latin America en_US
dc.subject human en_US
dc.subject Article en_US
dc.subject interferon en_US
dc.subject multiple sclerosis en_US
dc.subject South and Central America en_US
dc.subject immunologic factor en_US
dc.subject Immunologic Factors en_US
dc.subject immunogenicity en_US
dc.subject biosimilar agent en_US
dc.subject Multiple Sclerosis en_US
dc.subject drug approval en_US
dc.subject bioequivalence en_US
dc.subject Biosimilar Pharmaceuticals en_US
dc.subject biosimilars en_US
dc.subject Drug and Narcotic Control en_US
dc.subject drug control en_US
dc.subject drug manufacture en_US
dc.subject drug surveillance program en_US
dc.subject Expert Testimony en_US
dc.subject expert witness en_US
dc.subject glatiramer acetate en_US
dc.subject monoclonal antibodies en_US
dc.subject risk management en_US
dc.subject Risk Management en_US
dc.title Biological and nonbiological complex drugs for multiple sclerosis in Latin America: Regulations and risk management en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1586/14737175.2015.1042456
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.01.04
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.01.05


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