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Medicamentos Biotecnológicos: Requisitos Exigidos para el Desarrollo y Aprobación de Biosimilares
(Centro de Información Tecnológica, 2010)
Biological and nonbiological complex drugs for multiple sclerosis in Latin America: Regulations and risk management
(Taylor & Francis, 2015)
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 ...
Revisión del uso de los medicamentos biosimilares vs. biológicos: implicaciones para la salud en Colombia.
(Universidad del RosarioMaestría en Administración en SaludFacultad de administración, 2016)
This paper aims to describe the health implications with the use of biosimilars compared with biological drugs in Colombia. Also, described the regulatory context about the use of biosimilars, recommendations and guidelines ...
A bibliometric analysis of the global research on biosimilars
Background: Biosimilars could be a promising option to help decrease healthcare costs and expand access to treatment. There is no previous evidence of a global bibliometric analysis on biosimilars. Therefore, we aimed to ...
Mercado de medicamentos biotecnológicos en el Sistema General de Seguridad Social en SaludBiotechnological drug market in the General Social Security System in Health
(Universidad de La Salle. Revistas. Ciencia y Tecnología para la Salud Visual y Ocular., 2012)
Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America
(Wiley Blackwell, 2016)
Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the ...
Development Of Biosimilars In Brazil [desenvolvimento De Biossimilares No Brasil]
(OpenJournals Publishing, 2016)
Estudos de medicamentos biosimilares
In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acronym in Portuguese) is fully satisfied with the evidence of their quality, efficacy and safety, presented by a pharmaceutical ...