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New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
(Pro Pharma Communications International, 2016-06)
Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other ...
Biosimilar knowledge and viewpoints among Brazilian inflammatory bowel disease patients
(2021-01-01)
Background: In this analysis we aimed to describe Brazilian inflammatory bowel disease (IBD) patients’ knowledge and perceptions regarding biosimilars and compare with viewpoints from non-Brazilian patients. Methods: An ...
Biosimilars: An Approach to some Current Worldwide Regulation Frameworks
(Current Clinical Pharmacology, 2019-08)
Developing new biologics has led to regulations and norms aimed at guaranteeing their safety, quality and effectiveness, in terms of marketing, prescription, use, interchangeability and switching. Biologics are of great ...
Actualización en biosimilares : una reflexión sobre la reglamentación en Colombia de los medicamentos biológicos y biosimilaresBiosimilars update, a reflection on regulations in Colombia about biological and biosimilar medicines
(Asociación Colombiana de Dermatología y Cirugía DermatológicaCentro de de Investigaciones DermatológicasBogotá, Colombia, 2021)
Medicamentos Biotecnológicos: Requisitos Exigidos para el Desarrollo y Aprobación de Biosimilares
(Centro de Información Tecnológica, 2010)
Intercambiabilidad de biológicos de referencia a biosimilares en pacientes con enfermedades autoinmunes
(Universidad Peruana Cayetano HerediaPE, 2022)
El uso de productos biológicos es cada vez más frecuente en el tratamiento de enfermedades con alto grado de complejidad como las autoinmunes o el cáncer, las cuales generan un alto gasto económico para el paciente y en ...
Biological and nonbiological complex drugs for multiple sclerosis in Latin America: Regulations and risk management
(Taylor and 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 ...
Expression of cetuximab biosimilar for development of Immunonanoparticle: Strategies and targets for drug delivery proposal towards treatment of prostate cancer
(Fiocruz/Instituto de Tecnologia em Imunobiológicos, 2021)
Initial assays for the characterization of a biosimilar anti-PD-1 monoclonal antibody to Nivolumab
(Fiocruz/Instituto de Tecnologia em Imunobiológicos, 2019)
Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America
(2019)
The use of biosimilar drugs for multiple sclerosis (MS) has become widespread in Latin America, with the goal of reducing costs of treatments, promoting the sustainability of healthcare systems, and improving patient access ...