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ABSTRACT Despite availability of biologic therapies, limited patient access to many of the most-effective cancer treatments affects overall health outcomes. To address this issue, many governments have enacted legislation for the approval of biosimilars. The term "biosimilar" refers to a biologic product that is developed to be highly similar, as opposed to identical, to a licensed biologic product (the reference or innovator product), such that, per US Food and Drug administration draft guidelines, "no cli...
Biosimilars have been defined as biotech drugs that have been shown to have comparable quality, safety and efficacy to the original product. The past decade has seen a significant increase in interest in these products from the biotech industry. Major developments have occurred with respect to establishing a regulatory path for approval of these products as well as in our understanding of how the different quality attributes of a biosimilar impact its safety and efficacy. India is globally regarded to have ...
Brevipalpus phoenicis s.l. is an economically important vector of the Citrus leprosis virus-C (CiLV-C), one of the most severe diseases attacking citrus orchards worldwide. Effective control strategies for this mite should be designed based on basic information including its population structure, and particularly the factors that influence its dynamics. We sampled sweet orange orchards extensively in eight locations in Brazil and 12 in Mexico. Population genetic structure and genetic variation between both ...
Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem cell transplantation for haematological malignancies: a 4-year, single institute experience with different conditioning regimens.
Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients.
The goal is to review the most recent literature about biosimilars in inflammatory bowel disease (IBD), with emphasis on controversial regulatory issues.
The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this second part of the review, we will look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitutio...
The legume genus Mimosa has > 500 species, with two major centres of diversity, Brazil (c. 350 spp.) and Mexico (c. 100 spp.). In Brazil most species are nodulated by Burkholderia. Here we asked whether this is also true of native and endemic Mexican species. We have tested this apparent affinity for betaproteobacteria by examining the symbionts of native and endemic species of Mimosa in Mexico, especially from the central highlands where Mimosa spp. have diversified. Nodules were tested for betaproteobac...
Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory authorities around the world on approval of biosimilars and, where available, insulin biosimilars were reviewed. Information was sourced through Internet searching and cross-referencing guidelines. As of August 2014...
To provide clinicians with an overview of similar biologic products, including biosimilars and new insulin versions, available in the United States (US) and of key issues associated with such products, including differences in manufacturing, regulatory approaches, and their impact on clinical use.
Schistosomiasis, a parasitic disease, is an important public health issue in Brazil, particularly Northern Brazil. Since the first recorded occurrence of Biomphalaria glabrata in the States of Santa Catarina and Rio Grande do Sul, it has spread to South Brazil.
Research on early life socioeconomic status (SES), education and mortality is less established in developing countries. This analysis aims to determine how SES and education are patterned across the life course and associated with adult mortality in Mexico.
A new troglomorphic species, Phrynus perrii sp. nov., is described from two adult females from Cueva del Naranjo, Municipio Cintalapa, Chiapas, Mexico. This is the first continental record of a troglomorphic Phrynus species, and the second troglomorphic species of the genus. With the description of this species, in Mexico there are ten extant species, plus one fossil of the genus Phrynus, and it is the seventh species of troglobitic whip spiders from Mexico, making it the country with the highest richness o...
The evolutionary origins of the influenza A(H1N1)pdm09 virus that caused the first outbreak of the 2009 pandemic in Mexico remain unclear, highlighting the lack of swine surveillance in Latin American countries. Although Brazil has one of the largest swine populations in the world, influenza was not thought to be endemic in Brazil's swine until the major outbreaks of influenza A(H1N1)pdm09 in 2009. Through phylogenetic analysis of whole-genome sequences of influenza viruses of the H1N1, H1N2, and H3N2 subty...
To explore perceptions of healthcare providers and beneficiaries of Oportunidades program on physical activity during pregnancy and post-partum; and identify current reported practices related to counseling on physical activity in the primary healthcare services in Mexico.
Describe the trend in deaths by assault in women in Argentina, Brazil, Chile, Colombia, and Mexico between 2001 and 2011.
Problematic policing practices are an important driver of HIV infection among persons who inject drugs (PWID) in the U.S.-Mexico border region. This study identifies factors associated with recent (i.e., past 6 months) police victimization (e.g., extortion, physical and sexual violence) in the border city of Tijuana, Mexico.
In Brazil, imatinib mesylate is supplied as the first-line therapy for chronic myeloid leukemia in the chronic phase through the public universal healthcare program, Sistema Único de Saúde (SUS). We studied the socio-demographic factors that influenced therapy success in a population in the northeast region of Brazil.
Sensitization to allergens in atopic dermatitis patients is a risk factor for developing asthma and allergic rhinitis in the future,as well as an aggravating factor in the course of the disease. Recent studies have attributed the activity of the proteases of some antigens to cause a grater defect in the epithelial barrier and a more severe disease.
To obtain estimates of the effects of overweight and obesity on the incidence of type 2 diabetes (T2D) and adult mortality.