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

23:34 EDT 25th June 2017 | BioPortfolio

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Showing "Zydus spies opportunities Brazil Mexico along with biosimilars" PubMed Articles 1–25 of 2,900+

5th Update on Fabry Nephropathy: Biomarkers, Progression and Treatment Opportunities. April 25-27, 2017, Mexico City, Mexico: Abstracts.


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...

Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn's disease across Germany.

This study examined gastroenterologists' motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behaviour, and explored patient attitudes to biosimilars.

Educational Differences in Health Among Middle-Aged and Older Adults in Brazil and Mexico.

This study examines educational differences in health conditions among middle-aged and older adults in Brazil and Mexico.

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 ...

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.

Transportation Matters: A Health Impact Assessment in Rural New Mexico.

This Health Impact Assessment (HIA) informed the decision of expanding public transportation services to rural, low income communities of southern Doña Ana County, New Mexico on the U.S./Mexico border. The HIA focused on impacts of access to health care services, education, and economic development opportunities. Qualitative and quantitative data were collected from surveys of community members, key informant interviews, a focus group with community health workers, and passenger surveys during an initial i...

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...

The Biosimilar Pipeline Seams Seem To Be Bursting.

The biosimilar segment of the pharmaceutical industry is on fire. Some 700 biosimilars are at some stage of development, and more than 660 companies are involved in some way in the biosimilars land rush. Still, only a handful may get on the market in the next few years.

Biosimilars Ready, At Last, To Make Their Entrance: Stars Are Born or Do They Fizzle?

The future of biosimilars in this country is nothing if not uncertain. Most immediately, the U.S. Supreme Court is hearing a case that will determine the timing of the 180-day waiting period before a biosimilar can go on the market. But there are larger and longer-term issues at play as well.

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...

Adolescense pregnancy in a marginalized rural community in Mexico.

To identify objective and subjective conditions in the lives of pregnant teens within a highly-marginalized community in the state of Puebla, Mexico.

Evaluation of HIV, STI and CD4 results among voluntary attendees at the HIV/AIDS program of Mexico City.

To describe results of HIV, sexually transmitted diseases (STI) and CD4 counts at the HIV-specialized Condesa Clinic (CC) in Mexico City.

The Experience of Adolescent Motherhood: An Exploratory Mixed Methods Study.

To identify and better understand opportunities for and challenges to attaining the maternal role among women who began childbearing in adolescence in rural Mexico.

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,...

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.

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...

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.

Opportunities for women in sport in Brazil: Expectations after Rio 2016.


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