Trends and perspectives of biological drug approvals by the FDA: a review from 2015 to 2021

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dc.contributor.advisorPereira, Gustavo
dc.contributor.authorMartins, Alexander
dc.contributor.authorOshiro, Mariana
dc.coverage.spatialSão Paulopt_BR
dc.date.accessioned2022-12-07T13:01:41Z
dc.date.available2022-12-07T13:01:41Z
dc.date.issued2022-09-19
dc.description.abstractDespite belonging to a relatively new class of pharmaceuticals, biological drugs have been used since the 1980s, when they brought about a breakthrough in the treatment of chronic diseases, especially cancer. They conquered a large space in the pipeline of the pharmaceutical industry and boosted the innovation portfolio and arsenal of therapeutic compounds available. Here, we report on biological drug approvals by the US Food and Drug Administration (FDA) from 2015 to 2021. The number of drugs included in this class grew over this period, totaling 90 approvals, with an average of 13 authorizations per year. This figure contrasts with previous periods, which registered between 2 and 8 approvals per year. We highlight the great potential and advantages of biological drugs. In this context, these therapeutics show high efficacy and high selectivity, and they have brought about a significant increase in patient survival and a reduction of adverse reactions. The development and production of biopharmaceuticals pose a major challenge because these processes require cutting-edge technology, thereby making the drugs very expensive. However, we believe that, in the near future, biological medicines will be more accessible and new drugs belonging to this class will become available as new technologies emerge. Such advances will enhance the production of these biopharmaceuticals, thereby making the process increasingly profitable and less expensive, thereby bringing about greater availability of these drugs.en
dc.format.extent19 fpt_BR
dc.identifier.urihttps://repositorio.animaeducacao.com.br/handle/ANIMA/27425
dc.language.isoptpt_BR
dc.rightsAtribuição-NãoComercial-SemDerivados 3.0 Brasil*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/br/*
dc.subjectFood and Drug Administrationpt_BR
dc.subjectFDA approvalspt_BR
dc.subjectmonoclonal antibodypt_BR
dc.subjectantibody–drug conjugatept_BR
dc.subjectfirst global approvalpt_BR
dc.subjectbiological drugspt_BR
dc.titleTrends and perspectives of biological drug approvals by the FDA: a review from 2015 to 2021pt_BR
dc.typeArtigo Científicopt_BR
local.author.cursoFarmáciapt_BR
local.author.unidadeMooca / UAMpt_BR
local.contributor.coadvisorGonzaga, Rodrigo
local.dateissued.semester2pt_BR
local.modalidade.estudoPresencialpt_BR
local.rights.policyAcesso fechadopt_BR
local.subject.areaCiências da Saúdept_BR
local.subject.areaanimaCiências Biológicas & da Saúdept_BR

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