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

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Showing "Zydus spies opportunities Brazil Mexico along with biosimilars" PubMed Articles 1–25 of 2,800+

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Clinical considerations for the development of biosimilars in oncology.

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: where we were and where we are.

Abstract Recent progress in biosimilars development is overviewed, with attention to the history of issues and processes leading to current regulations, and to scientific considerations, including progress on design and operational implementation issues that arise and are peculiar to biosimilars trial design and implementation.

The advent of biosimilars: challenges and risks.

Biosimilars represent a new class of medicinal products that will have significant impact on clinical use. They are identical on an amino acid sequence level to existing reference biopharmaceutical products (originals). However, they may exhibit differences on a protein level. This paper provides a brief overview of biosimilar development and describes the risk and challenges that should be considered during the admission of biosimilars into the clinic.

Cancer research in Brazil - stuck in second gear?

This article describes the main issues regarding clinical cancer research in Brazil, including both the opportunities and the hurdles. Scientists and clinicians in this field had the opportunity to talk to regulatory agencies and to the Health Ministry representative at a meeting held in the State of Rio de Janeiro, Brazil, in April 2014. Our conclusions are that we do indeed have opportunities; however, we need to move forward regarding partnerships between academia and industry, increase the availability ...

Potential impact of a 9-valent HPV vaccine in HPV-related cervical disease in 4 emerging countries (Brazil, Mexico, India and China).

We estimated the potential impact of an investigational 9-valent human papillomavirus (HPV) vaccine (HPVs 6/11/16/18/31/33/45/52/58) in HPV-related cervical disease in Brazil, Mexico, India and China, to help to formulate recommendations on cervical cancer prevention and control.

Prevalent Tuberculosis (TB) at HIV diagnosis in Rio de Janeiro, Brazil: The TB/HIV in Rio (THRio) Cohort.

Although Brazil has model HIV care programs, many patients continue to present late to care. We studied the frequency of tuberculosis (TB) diagnosed at HIV diagnosis in Rio de Janeiro, Brazil, in order to quantify missed opportunities for TB prevention.

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Evolution of biologicals in inflammation medicine - Biosimilars in gastroenterology, rheumatology and dermatology.

Biologicals revolutionized the therapy of chronic inflammatory diseases in gastroenterology, rheumatology and dermatology in the last decade. The first generation biologicals mainly targeted against the pro-inflammatory cytokine TNF-α. The evolution of these therapies in the last years led to the development of new antibodies and to the admission of first generation "generic" biologics - the biosimilars. Biosimilars are not a fundamental new pharmacological development for existing substances, however they...

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.

Cancer genomes: where do we go from here?

In recent years there has been an exponential growth of knowledge of the molecular basis of cancer. In particular, the creation of important initiatives for the elucidation of the genomes of several types of cancer has allowed for the first time the creation of catalogs for most mutational events in diverse tumors, which opens up significant opportunities for oncology and public health. This review provides an overview of the progress and possible directions in Mexico.

An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins.

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...

Prevalence of pollinosis in patients with allergic asthma, rhinitis and conjunctivitis in the South of Mexico City 2007-2013.

The prevalence of pollinosis has doubled in the past two decades. Several studies suggest that up to 50% of adult residents of Mexico City can present manifestations of respiratory allergy, and pollens from trees, grasses and weeds are a common cause. To determine the prevalence of their families and antigenic cross-reactivity allows us to offer appropriate diagnoses and treatments.

Haplotype and nucleotide variation in the exon 3-VNTR of the DRD4 gene from indigenous and urban populations of Mexico.

To describe the population structure of the 48-bp variable number of tandem repeats (VNTR), located in exon 3 of the dopamine receptor D4 gene (DRD4), in 41 Tarahumara from northern Mexico, 20 Mixe from southern Mexico, and 169 people from Mexico City.

Antidotes and medicines used to treat poisoning in Brazil: needs, availability and opportunities.

Antidotes and certain other drugs are essential for treating some types of poisoning. Failures in their supply can jeopardize the population's health and safety. The current study aimed to assess the availability of antidotes and other drugs used in the treatment of poisonings in Brazil. International guidelines were used as the basis for selecting 41 antidotes for analysis, none of which currently protected by patents. Of these, 27 are registered in Brazil, but 11 of these are available in inadequate forms...

The first troglomorphic species of the genus Phrynus Lamarck, 1801 (Amblypygi: Phrynidae) from 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...

Biosimilars entering the clinic without animal studies.

The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing should follow a step-wise approach rather than being performed by default. To not require animal testing at all in some instances can well be seen as a revolutionary, but science-based, step. Here, we describe th...

Biosimilars: Are They Bioequivalent?

Biologics have revolutionized several areas of medical therapeutics, and dozens of them are used by millions of patients. Monoclonal antibodies are only one type of biologics, but more than 900 are now in different phases of development. These drugs are complex to make and not cheap. The market is constantly increasing, and several biosimilars (copies of biologics) are being used, while many are still waiting to become available to the public. Biosimilars are more complex than generics, and regulatory agenc...

Barriers to the Use of Trastuzumab for HER2+ Breast Cancer and the Potential Impact of Biosimilars: A Physician Survey in the United States and Emerging Markets.

Trastuzumab in combination with chemotherapy has become a standard of care for patients with HER2+ breast cancer. The cost of therapy, however, can limit patient access to trastuzumab in areas with limited financial resources for treatment reimbursement. This study examined access to trastuzumab and identified potential barriers to its use in the United States, Mexico, Turkey, Russia and Brazil via physician survey. The study also investigated if the availability of a biosimilar to trastuzumab would improve...

Alergia México: an Ibero-American journal.

Biosimilars.

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The role of visual markers in police victimization among structurally vulnerable persons in Tijuana, Mexico.

Law enforcement can shape HIV risk behaviours and undermine strategies aimed at curbing HIV infection. Little is known about factors that increase vulnerability to police victimization in Mexico. This study identifies correlates of police or army victimization (i.e., harassment or assault) in the past 6 months among patients seeking care at a free clinic in Tijuana, Mexico.

First biosimilars trickle into US pathway.

FDA sets hierarchy for biosimilars evidence.

Urticaria in children attending allergy services.

There is little information on urticaria occurring in children, especially in limited resource countries.

Identification of OXA-23 carbapenemases: novel variant OXA-239 in Acinetobacter baumannii ST758 clinical isolates in Mexico.

A collection of 15 carbapenem-resistance Acinetobacter baumannii clinical isolates was analysed on two tertiary hospitals in Mexico. The OXA-51 was identified in all isolates, followed by OXA-239 and OXA-58; OXA-239 is described as a new OXA-23-like allele. These carbapenemases were identified on four clonal groups, distributed between two neighbouring hospitals. Acinetobacter baumannii is poorly studied in Mexico; this situation urges the implementation of strategies to prevent its dissemination.

Policy Development for Environmental Licensing and Biodiversity Offsets in Latin America.

Attempts to meet biodiversity goals through application of the mitigation hierarchy have gained wide traction globally with increased development of public policy, lending standards, and corporate practices. With interest in biodiversity offsets increasing in Latin America, we seek to strengthen the basis for policy development through a review of major environmental licensing policy frameworks in Argentina, Brazil, Chile, Colombia, Mexico, Peru and Venezuela. Here we focused our review on an examination of...


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