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‣ Impact of Biosimilars in Psoriasis Treatment

Torres, T.; Filipe, P.; Selores, M.
Fonte: Centro Editor Livreiro da Ordem dos Médicos Publicador: Centro Editor Livreiro da Ordem dos Médicos
Tipo: Artigo de Revista Científica
Publicado em //2013 Português
Relevância na Pesquisa
27.70802%

‣ BIOSIMILARS IN INFLAMMATORY BOWEL DISEASES: an important moment for Brazilian gastroenterologists

TEIXEIRA,Fábio Vieira; KOTZE,Paulo Gustavo; DAMIÃO,Aderson Omar Mourão Cintra; MISZPUTEN,Sender Jankiel
Fonte: Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia - IBEPEGE ; Colégio Brasileiro de Cirurgia Digestiva - CBCD ; Sociedade Brasileira de Motilidade Digestiva - SBMD ; Federação Brasileira de Gastroenterologia - FBG; Sociedade Brasileira de Hepatologia - SBH; Sociedade Brasileira de Endoscopia Digestiva - SOBED Publicador: Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia - IBEPEGE ; Colégio Brasileiro de Cirurgia Digestiva - CBCD ; Sociedade Brasileira de Motilidade Digestiva - SBMD ; Federação Brasileira de Gastroenterologia - FBG; Sociedade Brasileira de Hepatologia - SBH; Sociedade Brasileira de Endoscopia Digestiva - SOBED
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/03/2015 Português
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38.29415%
ABSTRACT Biosimilars are not generic drugs. These are more complex medications than small molecules, with identical chemical structures of monoclonal antibodies that lost their patency over time. Besides identical to the original product at the end, the process of achieving its final forms differs from the one used in the reference products. These differences in the formulation process can alter final outcomes such as safety and efficacy of the drugs. Recently, a biosimilar of Infliximab was approved in some countries, even to the management of inflammatory bowel diseases. However, this decision was based on studies performed in rheumatologic conditions such as rheumatoid arthritis and ankylosing spondylitis. Extrapolation of the indications from rheumatologic conditions was done for Crohn’s disease and ulcerative colitis based on these studies. In this article, the authors explain possible different mechanisms in the pathogenesis between rheumatologic conditions and inflammatory bowel diseases, that can lead to different actions of the medications in different diseases. The authors also alert the gastroenterological community for the problem of extrapolation of indications, and explain in full details the reasons for being care with the use of biosimilars in inflammatory bowel diseases without specific data from trials performed in this scenario.

‣ Generic versus branded enoxaparin in prophylaxis and treatment of vein thrombosis

Casella,Ivan Benaduce; Puech-Leão,Pedro
Fonte: Associação Médica Brasileira Publicador: Associação Médica Brasileira
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/02/2015 Português
Relevância na Pesquisa
27.70802%
Objectives: to compare the biological efficacy of generic enoxaparin (HeptronTM) versus branded Sanofi-Aventis enoxaparin for prophylaxis and treatment of lower-extremity deep venous thrombosis (DVT) in a prospective, randomized, open-label study. Methods: patients with diagnosed lower-extremity DVT (therapeutic branch, n=57) and patients requiring venous thromboembolism (VTE) prophylaxis after arterial vascular surgery or major lower-extremity amputations (prophylactic branch, n=57) were randomized to receive generic or branded enoxaparin for up to seven days. Enoxaparin activity was measured by estimating blood anti-factor Xa levels at the peak plasma concentration. As secondary outcomes, development or progression of VTE events, major adverse events and major bleeding events were considered for efficacy and safety comparisons. Results: DVT therapy: twenty-five patients received generic enoxaparin while 32 received branded enoxaparin (subcutaneous, 1 mg/kg BID). Mean percentages of anti-factor Xa levels within the target ranges were 62 ± 35.4% and 67.5 ± 24.7%, respectively (p= .035 for non-inferiority). No patient presented DVT progression, clinically detectable pulmonary embolism, or major bleeding events in any subgroup. DVT prophylaxis: Thirty patients received generic enoxaparin and 27 received branded enoxaparin (subcutaneous...

‣ A Review of Approaches for the Management of Specialty Pharmaceuticals in the United States

Patel, Bijal Nitin; Audet, Patricia R.
Fonte: Springer International Publishing Publicador: Springer International Publishing
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
28.594478%
With increased innovation and development of specialty pharmaceuticals, the US and global healthcare industries are looking to implement appropriate management strategies to control both utilization and costs. Specialty pharmaceuticals are high-cost medications that treat complex, chronic, rare, and difficult-to-manage conditions. These drugs require special drug handling, appropriate clinical outcomes monitoring, and effective cost controls. The primary scope of this article is to discuss various strategies being implemented for specialty pharmaceutical utilization and cost management and correlated outcomes in the USA; these outcomes include enhanced health insurance plan benefit designs with formulary modifications and greater patient cost burden. Additional methods to manage specialty pharmaceuticals include the use of specialty pharmacies for drug distribution, increased emphasis on coordination of care and evidence-based medicine, as well as healthcare reform and regulations. Healthcare spending, both in the US and globally, continues to increase, with a rising proportion of drug spend towards specialty pharmaceuticals. Continued specialty pharmaceutical innovation and introduction of biosimilar products will evolve the currently utilized management strategies for these drugs.

‣ Development of biosimilars in an era of oncologic drug shortages

Li, Edward; Subramanian, Janakiraman; Anderson, Scott; Thomas, Dolca; McKinley, Jason; Jacobs, Ira A
Fonte: Dove Medical Press Publicador: Dove Medical Press
Tipo: Artigo de Revista Científica
Publicado em 24/06/2015 Português
Relevância na Pesquisa
17.70802%
Acute and chronic shortages of various pharmaceuticals and particularly of sterile injectable products are being reported on a global scale, prompting evaluation of more effective strategies to manage current shortages and development of new, high-quality pharmaceutical products to mitigate the risk of potential future shortages. Oncology drugs such as liposomal doxorubicin and 5-fluorouracil represent examples of first-choice drugs critically affected by shortages. Survey results indicate that the majority of hospitals and practicing oncologists have experienced drug shortages, which may have compromised patient safety and clinical outcomes, and increased health care costs, due to delays or changes in treatment regimens. Clinical trials evaluating novel agents in combination with standard-of-care drugs are also being affected by drug shortages. Clinical and ethical considerations on treatment objectives, drug indication, and availability of alternative options may help in prioritizing cancer patients involved in active drug shortages. The United States Food and Drug Administration and the European Medicines Agency have identified manufacturing problems, delays in supply, and lack of available active ingredients as the most frequent causes of recent or ongoing drug shortages...

‣ Biosimilars 2.0: Guiding principles for a global “patients first” standard

Miletich, Joseph; Eich, Geoffrey; Grampp, Gustavo; Mounho, Barbara
Fonte: Landes Bioscience Publicador: Landes Bioscience
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
17.70802%
In the European Union, biosimilar products have been approved since 2006 under an abbreviated pathway that leverages their similarity to an existing “reference” biological product. The products approved to date are based on recombinant versions of endogenous proteins with well-understood structures and pharmacology, but complicated safety and immunogenicity profiles. The period during the 2000s that included the first reviews, approvals, sale and use of biosimilars is referred to herein as “Biosimilars 1.0.” Over the next several years, a new and advanced tranche of biosimilars will be developed for complex reference products, including medicines used in the treatment of cancer and autoimmune diseases. A global market for biosimilars is developing and this may well foreshadow the beginning of the second era of product development. This Biosimilars 2.0 period will likely be characterized by the development of complex products, global harmonization of standards and the increasing demand for long-term monitoring of pharmaceuticals. The products developed in this period should exhibit high levels of fidelity to the reference products and should be rigorously evaluated in analytical, non-clinical and clinical comparisons. Additionally...