Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America.

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 to these therapies. There is currently a need to define and comply with requirements to guarantee the efficacy, safety, and quality of these drugs. Thus, the objective of the present study was to compile up-to-date information from each Latin American country assessed on (a) approval of biosimilar drugs by regulatory agencies; (b) use of biosimilar drugs, pharmacovigilance plans, risk management; and (c) update in the knowledge on different molecules. To do so, a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay, and Venezuela met to discuss the current situation regarding good practices and risks associated with the use of biosimilar drugs in their respective countries. Regulation, risk management plans, and pharmacovigilance in the whole continent must guide the strategies on the commercialization and access of biosimilar drugs and copies of complex molecules. Current regulations must be implemented for the registration of biosimilar drug products and complex molecules. It is paramount to ensure that new products follow the best quality standards at all stages beyond being safe and efficient. Uncontrolled interchangeability between original biological and biosimilar should be avoided. Latin America requires the implementation and full use of strong pharmacovigilance programs. National and multinational clinical studies are required to demonstrate the similarity in safety, efficacy, and immunogenicity profiles of complex molecules, as well as biological and biosimilar products. Plain language summary available for this article.

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

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.

Sepsis neonatal: Hospital "Patrocinio Peñuela Ruiz" años 1986-1990 / Neonatal sepsis: Hospital \"Patrocinio Peñuela Ruiz\" years 1986-1990

Entre los años 1986-1990 se reportaron en la admisión del Hospital Patrocinio Peñuela Ruíz, 20 casos de Sepsis Neonatal. El 10 por ciento procedia de Partos Eutócicos menores de 20 semanas de gestación. Un 40 por ciento de las madres presentaron líquido meconial fétido. El sexo femenino predominó en un 65 por ciento del 15 por ciento de Prematuros, el 75 por ciento de éstos desarrollo Sepsis Neonatal. El 20 por ciento consultó por fetidez umbilical, mientras el 55 por ciento lo ocuparon las Infecciones Nosocomiales. El 50 por ciento egresó con Diagnóstico definitivo de Sepsis. El 98 por ciento de los casos evolucionó satisfactoriamente con la terapéutica utilizada