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Zydus Spies Opportunities Brazil Mexico Along With Biosimilars PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Zydus Spies Opportunities Brazil Mexico Along With Biosimilars articles that have been published worldwide.
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The European Medicines Agency (EMA) recently approved the first anti-TNF-alpha biosimilar for infliximab (CT-P13) (trade names: Inflectra(®) and Remsima(®)) in Germany. Over the past year, German gastroenterologists gained experience treating IBD-patients with infliximab biosimilars (IFX-biosimilars). To evaluate their experiences and opinions on biosimilars, we conducted a nationwide online survey among German gastroenterologists. Our results are based on the assessment of 449 questionnaires. Although 61...
Biosimilar medicinal products (biosimilars) have been available in Europe for 10 years, allowing a wide use particularly in oncology. Biosimilars are being developed and approved by means of scientifically sound principles to assure close similarity with the reference products with regard to quality, efficacy, and safety. The scientific principles for establishing biosimilarity are the same as those for demonstrating comparability after a change in the manufacturing process of an already licensed biological...
To estimate economic impact resulting from increased biologics use for treatment of rheumatoid arthritis (RA) and Crohn's disease (CD) in Argentina, Brazil, Colombia, and Mexico.
Three new species of the ditomyiid genus Calliceratomyia Lane, so far known only from the type-species from southeastern Brazil, are described from Mexico. The new species-Calliceratomyia papaveroi sp. n., Calliceratomyia pantelhomyia sp. n. and Calliceratomyia zayolli sp. n.-are described based on adult males collected with Malaise traps in the States of Oaxaca, Chiapas and Hidalgo, Mexico. The descriptions are illustrated and the diagnosis of the genus is revised.
The Biosimilars Forum conducted a survey through an independent organization from November 20, 2015 to January 4, 2016 in order to assess current levels of awareness, knowledge, and perceptions of biosimilars among US specialty physicians who already prescribe biologics. The survey was intended to provide a baseline level of knowledge about biosimilars and will be repeated in 2-3 years in order to monitor trends over time.
No matter how you slice it, 2016 was a banner year for biosimilars. Still, the high-stakes marketing, regulatory, and legal combat between originators and biosimilars is a long way from over. So far, the originators have been able to hold their ground and thwart the launch of biosimilars with patent lawsuits.
Centromacronema is an endemic genus from the Neotropics, with distribution ranging from Mexico to southern Brazil. The genus comprises 15 described species, but only two of them have been recorded in Brazil: Centromacronema auripenne (Rambur 1842) and C. obscurum (Ulmer 1905). Two new species are herein described and illustrated from Brazil, C. pioneira n. sp. from Serra da Jiboia, Bahia state, including the first description of a female for the genus, and C. poyanawa n. sp. ...
Biosimilars use raises uncertainties with regards to efficacy despite potentially significant cost reductions. This requires a classical harm-benefit analysis. Important stakeholders include physicians and patients, companies producing biologica (drugs containing biotechnology-derived proteins as active substance), and companies producing biosimilars, as well as health insurance companies and politicians. They all have their distinct interests. In a rule-setting process, transparency is needed to protect th...
Although biosimilars approved in the European Union have proved to be safe and efficacious, their licensing requirements continue to be disputed by medical professionals. In particular, extrapolation to indications of the originator without one's own clinical data of the biosimilar is controversial. Conceptually, the development of biosimilars is derived from that of generics. However, due to their complexity and inherent variability, considerably more data are necessary for biosimilars to demonstrate compa...
With the expiration of patent protection for several biologics looming, the production of highly similar therapeutic agents has begun to emerge on the pharmaceutical market. These alternative drugs are referred to as biosimilars. Many anticipate that the introduction of these agents will result in a reduction in health care costs, which may create a more affordable biopharmaceutical market and also improve patient access. In contrast to generics, which are exact copies of their original products, biosimilar...
Biosimilars are drugs that are similar, but not identical, to originator biologics. Pre-clinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to ultimately determine biosimilarity. In this review written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability, and optimal clinical trial d...
In 2006, Omnitrope (by Sandoz) was the first approved biosimilar in Europe. To date, 21 biosimilars for seven different biologics are on the market. In this paper, the clinical trials undertaken to get market authorisation are compared.
This study aims to generate evidence on intellectual development disorders (IDD) in Mexico.
To analyze trends from 2000 to 2012 in socioeconomic inequalities in health related to diabetes and hypertension indicators in Mexico.
In Mexico the Psorophora genus includes 24 species divided into 3 subgenera: Grabhamia, Janthinosoma, and Psorophora. Some species occur in the Nearctic region of the country (northern Mexico), whereas other species occur in the Neotropical region (southern Mexico), and a few species occur in both regions. In Quintana Roo, Mexico, 7 species have been previously recorded: Ps. confinnis s.s., Ps. champerico, Ps. cyanescens, Ps. ferox, Ps. lutzii, Ps. ciliata, and Ps. lineata. In October 2013, 24 females of Ps...
Ambaeolothrips gen. n. is diagnosed for three Neotropical species: the type species romanruizi Ruiz-De la Cruz et al. comb. n. from Mexico, microstriatus Hood comb. n. from Panama, and pampeanus sp. n. from southern Brazil. Variation is discussed among character states that are used in the generic classification of the family Aeolothripidae, including segmentation of the antennae and maxillary palps, sculpture of the metanotum and presence of sternal discal setae. New field observations on the biology of ro...
Biotechnology has enabled the development of treatments for many diseases benefiting millions of people. Similar biologics or 'biosimilar' versions of originator biologic medicines are a relatively new category of biologics, usually developed when the originator is protected by patent exclusivity and introduced to healthcare systems as a cheaper option to treat disease. Biosimilars provide value and thus access for new groups of patients because they bring cost savings to the healthcare ecosystem. Generics ...
The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although bi...
To analyze inequalities in health care indicators of children 0 to 9 years old in Mexico reporting gap and gradient measures.
Two new species of Oukuriella, O. angelomachadoi sp. nov. (Holotype male deposited in MZUSP: BRAZIL, Paraná State) and O. plumaterata sp. nov. (Holotype male deposited in MZUSP: BRAZIL, São Paulo State), and the immatures stages of O. sublettei are described and figured. The larvae of O. sublettei were collected from submerged woods in low-order streams in the Atlantic Forest. In addition new records of several described species, including the first records of Oukuriella from Mexico and Bolivia are given.
Limited serosurveillance studies suggested that orthopoxviruses (OPXV) are widespread in the US (e.g., Raccoonpox virus, Skunkpox virus, Volepox virus) and Brazil (Vaccinia virus); however, their animal reservoir(s) remain unconfirmed. Mexican mammal diversity includes several species related to those in which evidence for OPXV infections has been found (Oryzomys, Peromyscus, Microtus, and Procyonidae). The presence of these groups of mammals in Mexico and the evidence of their possible involvement in the m...
Following the market authorization of the first insulin biosimilar in 2014, further approvals are to be expected due to patent expiry of several originator insulins. Knowledge of the manufacturing and the characteristics of these pharmaceutical products is important for their rationale and safe use by the physician, the pharmacist and the patient.Biosimilars are not generics, but similar or comparable, yet not identical versions of the originator biopharmaceutical. Marketing authorization in the EU is grant...
Brazil has received influxes of people, mainly from Africa, Europe and Japan, forming one of the most heterogeneous populations in the world. Some groups, particularly in Southern Brazil, have retained their original cultural traditions, whilst acquiring elements of the typical local Brazilian cultural identity. This is the first study designed to formally evaluate biculturality in Brazil.
To document socioeconomic health inequalities on adolescents' risk behaviors in Mexico using gap and gradient measures.
Biosimilars are subject to the efficiency evaluation according to section 106 Social Code Book Five (SGB V). The specific evaluation method influences the physician's prescription behaviour. In the case of an individual prescription limit evaluation (Richtgrößenprüfung), the prescription of biosimilars would usually not result in recourse but, as a start, in the initiation of the evaluation proceedings. Starting from 2017, the individual prescription limit evaluation will be cancelled. The active ingredi...