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PubMed Journals Articles About "Zydus Spies Opportunities Brazil Mexico Along With Biosimilars" RSS

04:02 EDT 28th March 2017 | BioPortfolio

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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Showing "Zydus spies opportunities Brazil Mexico along with biosimilars" PubMed Articles 1–25 of 3,000+

Biosimilars in Inflammatory Bowel Disease (IBD): Experiences and perceptions of german gastroenterologists.

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...


Biosimilars in oncology: a therapeutic alternative to the reference products?

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...

Biosimilars: implications for rheumatoid arthritis therapy.

Abbreviated pathways for the approval of biosimilars have been established in the European Union (EU), the United States, and other countries. Biosimilar TNF inhibitors have been available in South Korea and the EU since 2012 and 2013, respectively, and the first biosimilar infliximab was introduced to the clinic in the United States in November 2016. Five TNF inhibitor biosimilars have now been approved, and many other biosimilars to treat rheumatoid arthritis and other inflammatory diseases are in develop...


Economic impact of expanded use of biologic therapy for the treatment of rheumatoid arthritis and Crohn's disease in Argentina, Brazil, Colombia and Mexico.

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 Calliceratomyia Lane (Diptera: Ditomyiidae) from Neotropical 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.

Biosimilars in psoriasis: the future or not?

As patents for the biologic agents reach their expiration dates, dermatologists must prepare for the coming of biosimilars. These agents have been deemed "highly similar" to their reference products in a process outlined by the US Food and Drug Administration (FDA). In 2016, the FDA approved 3 biosimilars for various indications including plaque psoriasis and psoriatic arthritis. However, biosimilars are not the same as small-molecule generics because they have a complex manufacturing process that makes it ...

Two new species of the genus Centromacronema Ulmer 1905 (Hydropsychidae: Macronematinae) from Brazil.

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. ...

Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians.

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.

Patent litigation could make 2017 no 'dancing' matter.

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.

Biosimilars in Gastroenterology - how much uncertainly is ethically acceptable?

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...

Opportunities and challenges of extrapolation for biosimilars.

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...

The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects.

Biologic therapies have revolutionized treatment of a number of diseases. Patents and exclusivity for a number of biologics are expiring. This has created the opportunity for the development and approval of biosimilars. Biosimilars are biologic products developed using a step-wise approach to result in a biologic that demonstrates no clinically meaningful differences in terms of quality attributes, efficacy, safety, and immunogenicity compared with an existing licensed, originator biologic. As more biosimil...

Biosimilars: potential implications for clinicians.

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 for Psoriasis: Clinical Studies to Determine Similarity.

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...

The Path of Interchangeability of Biosimilars in Pediatric Inflammatory Bowel Disease: Quality Before Cost-Savings.

The advent of biosimilars in inflammatory bowel disease (IBD) represents an opportunity for cost-savings and increased patient access to effective disease-modifying therapies. While preliminary data in adult IBD and rheumatology patients suggest comparable effectiveness and pharmacokinetics between original biologics and biosimilars, long-term immunogenicity data are unknown. Without this data, conclusions about interchangeability should not be made for pediatric patients with IBD. Children affected by IBD,...

Clinical trials for authorised biosimilars in the European Union: A systematic review.

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.

The intellectual developmental disorders Mexico study: situational diagnosis, burden, genomics and intervention proposal.

This study aims to generate evidence on intellectual development disorders (IDD) in Mexico.

Inequalities on indicators of chronic conditions among adults in Mexico: analysis of three health surveys.

To analyze trends from 2000 to 2012 in socioeconomic inequalities in health related to diabetes and hypertension indicators in Mexico.

Ambaeolothrips: a new genus of Neotropical Aeolothripidae (Thysanoptera), with observations on the type-species from mango trees in Mexico.

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...

First Record of Psorophora albipes in Quintana Roo, 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...

Biosimilar Medicines Group - 14th Annual Medicines for Europe Conference (April 28-29, 2016 - London, UK).

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 ...

Biosimilar medical products - licensing, pharmacovigilance and interchangeability.

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...

Health inequality on results and access indicators for children in Mexico: analysis of national health surveys.

To analyze inequalities in health care indicators of children 0 to 9 years old in Mexico reporting gap and gradient measures.

New species and records of Oukuriella Epler, 1986 from the Neotropical region (Diptera: Chironomidae).

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.

Using the Portuguese version of the Bicultural Scale in Brazil.

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.


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