Abstract:
:Biotechnologicals are an invaluable resource in the treatment of patients with inflammatory rheumatic diseases (IRD) non-responsive or intolerant to conventional therapies. However, they are the main driver for increase in direct costs and represent a significant economic burden to healthcare systems worldwide. Since biosimilars are similar and more affordable versions of previously licenced biotechnologicals, they are expected to contribute to healthcare system sustainability and reduce inequities in treatment access. The landmark approval of CT-P13 as the first infliximab biosimilar paved the way for new infliximab but also etanercept, adalimumab and rituximab biosimilars. In Europe, North America and some countries of Asia, development is strictly regulated and only those presenting a totality-of-evidence dossier with highly similar physicochemical, biological and clinical performances are endorsed by regulatory agencies as biosimilars. The current article addresses the importance of biosimilar medicines in the treatment of IRD, as well as their innovative development and regulatory pathways, clinical evidence of similarity and challenges that may undermine their widespread use and success.
journal_name
Pharmacol Resjournal_title
Pharmacological researchauthors
Araújo FC,Gonçalves J,Fonseca JEdoi
10.1016/j.phrs.2019.104467subject
Has Abstractpub_date
2019-11-01 00:00:00pages
104467eissn
1043-6618issn
1096-1186pii
S1043-6618(19)31113-2journal_volume
149pub_type
杂志文章,评审abstract:AIM:To evaluate canrenone effects compared to other therapies on cardiovascular mortality in patients with chronic heart failure (CHF) and preserved systolic function after 10 years of evaluation. METHODS:We enrolled 532 patients with CHF and preserved systolic function. Patients were followed with a mean follow-up of...
journal_title:Pharmacological research
pub_type: 杂志文章,多中心研究
doi:10.1016/j.phrs.2018.11.037
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abstract::Short-chain fatty acids (SCFAs), mainly including acetate, propionate, and butyrate, are metabolites produced during the bacterial fermentation of dietary fiber in the intestinal tract. They are believed to be essential factors affecting host health. Most in vitro and ex vivo studies have shown that SCFAs affect the r...
journal_title:Pharmacological research
pub_type: 杂志文章,评审
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abstract::It has been reported that patients with Hodgkin's disease (HD) show altered porphyrin metabolism, and suggested that the cause is the neoplastic process itself. If this is true, disease progression should be associated with higher levels of porphyrin excretion. The aim of this study was to evaluate urinary coproporphy...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2004.09.005
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abstract::We investigated the anti-platelet effect of a newly synthesized guanidine derivative KR-32560, a sodium/hydrogen exchanger-1 (NHE-1) inhibitor, together with the elucidation of the possible mode of action. KR-32560 concentration dependently inhibited the aggregation of washed rabbit platelets induced by collagen (10 m...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2005.12.003
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abstract::With more than four decades of clinical research and 25 years of clinical trials, much is known about the natural history of T1D before and after clinical diagnosis. We know that autoimmunity occurs early in life, that islet autoimmunity inevitably leads to clinically overt disease, and that some immune therapies can ...
journal_title:Pharmacological research
pub_type: 杂志文章,评审
doi:10.1016/j.phrs.2015.02.002
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abstract::A global transcriptional regulator, MgrA, was previously identified as a key determinant of virulence in Staphylococcus aureus. An 80% EtOH extract of Uncaria gambier was found to attenuate the virulence of S. aureus via its effects on MgrA. Using bioassay-guided fractionation, a polyphenolic polymer, uncariitannin, w...
journal_title:Pharmacological research
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doi:10.1016/j.phrs.2019.104328
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abstract::The hepatoprotective effects of acetylbergenin were examined against D -galactosamine (GalN)-induced liver damage in rats, compared with that of bergenin reported previously. Acetylbergenin was synthesized from acetylation of bergenin, isolated from Mallotus japonicus, to increase lipophilic and physiological activiti...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1006/phrs.2000.0730
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abstract::MicroRNAs (miRNAs) are small non-coding RNAs that regulate post-transcriptional gene expression by targeting specific mRNAs for degradation or translation repression. Changes in miRNAs expression profiles have been reported in several neurodegenerative disorders such as Alzheimer's disease (AD) and related tauopathies...
journal_title:Pharmacological research
pub_type: 杂志文章,评审
doi:10.1016/j.phrs.2020.104729
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journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/s1043-6618(05)80116-1
更新日期:1991-02-01 00:00:00
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journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2010.01.008
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abstract::Cocoa contains flavonoids with antioxidant properties. The aim of this study was to ascertain the effect of cocoa intake on oxidative stress associated with a model of chronic inflammation such as adjuvant arthritis. Female Wistar rats were fed with a 5% or 10% cocoa-enriched diet or were given p.o. a quercetin suspen...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2012.05.009
更新日期:2012-09-01 00:00:00
abstract::The interaction of mianserin with ethanol in central nervous system (CNS) was investigated. Mianserin was administered at a single dose of 5 or 20 mgkg(-1) i.p. or as daily injections in a dose of 2.5 mgkg(-1) given for 14 days. The influence of mianserin on acute ethanol toxicity (LD(50)), on ED(50) of ethanol in rot...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/s1043-6618(02)00031-2
更新日期:2002-07-01 00:00:00
abstract::Endocannabinoids exhibit vasodilatory properties and reduce blood pressure in vivo. However, the influence and mechanism of action of the prominent endocannabinoid, anandamide (AEA), in pulmonary arteries are not known. The present study determined the vascular response to AEA in isolated rat pulmonary arteries. AEA r...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2012.05.004
更新日期:2012-09-01 00:00:00
abstract::The effects of betel leaf extract (0.10, 0.40, 0.80 and 2.0 g kg-1 day-1 for 15 days) on the alterations in thyroid hormone concentrations. lipid peroxidation (LPO) and on the activities of superoxide dismutase (SOD) and catalase (CAT) were investigated in male Swiss mice. Administration of betel leaf extract exhibite...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1006/phrs.1998.0398
更新日期:1998-12-01 00:00:00
abstract::In the present study, we have investigated the effects of centrally administered ginsenoside Rc and Rg1 on the modulation of the NMDA receptor and GABA(A)receptor binding in rat brain. The NMDA receptor binding was analysed by quantitative autoradiography using [(3)H]MK-801 binding, and the GABA(A)receptor bindings we...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1006/phrs.2001.0809
更新日期:2001-05-01 00:00:00
abstract::Combination antiretroviral therapy reduces morbidity and mortality in HIV infected patients. However, the cure of HIV infection is hindered by the persistence of the latent HIV reservoir. Latency reversing agents (LRAs) are developed to target the HIV latently infected cells for HIV reactivation. In addition to revers...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2018.10.023
更新日期:2019-01-01 00:00:00
abstract::Monoamine oxidases (MAO) are mitochondrial enzymes that catalyze the oxidation of monoamines in multiple tissues, including the brain. Elevated MAO activity has long been implicated in the etiology of depression, anxiety, and neurodegenerative disease, fuelling the search for inhibitors in the prevention and treatment...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2009.01.014
更新日期:2009-05-01 00:00:00
abstract::Pharmacokinetic of methyldopa (50 mg kg(-1)i.p.) was studied in anesthetized sham operated and sinoaortic denervated (SAD) rats by using the microdialysis technique. Vascular shunt probe was inserted into the carotid artery and concentric probe was placed in the striatum. Levels of methyldopa were measured by HPLC-EC....
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1006/phrs.1999.0610
更新日期:2000-04-01 00:00:00
abstract::The endogenous gasotransmitter hydrogen sulphide (H2S) is an important regulator of the cardiovascular system, particularly of myocardial function. Moreover, H2S exhibits cardioprotective activity against ischemia/reperfusion (I/R) or hypoxic injury, and is considered an important mediator of "ischemic preconditioning...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2016.09.006
更新日期:2016-11-01 00:00:00
abstract::Advanced glycation end-products (AGE) and the receptor for AGE (RAGE) have been linked to numerous diabetic vascular complications. RAGE activation promotes a self-sustaining state of chronic inflammation and has been shown to induce apoptosis in various cell types. Although previous studies in vascular smooth muscle ...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2015.12.015
更新日期:2016-02-01 00:00:00
abstract::Mammals and their intestinal microbiota peacefully coexist in a mutualistic relationship. Commensal bacteria play an active role in shaping and modulating physiological processes in the host, which include, but are not restricted to, the immune system and the intestinal barrier. Both play a crucial role in containing ...
journal_title:Pharmacological research
pub_type: 杂志文章,评审
doi:10.1016/j.phrs.2012.10.007
更新日期:2013-03-01 00:00:00
abstract::Parkinson's disease is a progressive age-related neurodegenerative disease with invariant loss of substantia nigra dopamine neurons and striatal projections. This disorder is well known for the associated motoric symptoms including resting tremor and the inability to initiate movement. However, it is now apparent that...
journal_title:Pharmacological research
pub_type: 杂志文章,评审
doi:10.1016/j.phrs.2008.09.006
更新日期:2008-11-01 00:00:00
abstract::The concentration of five lipid-soluble antioxidants (gamma- and alpha-tocopherol, lycopene, beta-carotene and ubiquinol-10) was measured in plasma and very low-density, low-density and high-density lipoproteins (VLDL, LDL and HDL) isolated from young healthy normo- cholesterolemic subjects. Alpha-tocopherol was the e...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1006/phrs.1999.0552
更新日期:2000-01-01 00:00:00
abstract::Treatment of MC3T3E-1 osteoblast cultures with combined interferon- gamma(IFN- gamma), lipopolysaccharide (LPS) and tumor necrosis factor- alpha(TNF- alpha) induces expressions of inducible nitric oxide synthase (iNOS) and interleukin-6 (IL-6), resulting in sustained releases of large amounts of nitric oxide and IL-6....
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1006/phrs.2000.0778
更新日期:2001-03-01 00:00:00
abstract::Mitochondria are best known for their role in ATP generation. However, studies over the past two decades have shown that mitochondria do much more than that. Mitochondria regulate both necrotic and apoptotic cell death pathways, they store and therefore coordinate cellular Ca2+ signaling, they generate and metabolize ...
journal_title:Pharmacological research
pub_type: 杂志文章,评审
doi:10.1016/j.phrs.2018.08.010
更新日期:2018-12-01 00:00:00
abstract::Mechanism of interaction of non-steroidal anti-inflammatory drugs, celecoxib and valdecoxib with human serum albumin has been studied using fluorescence spectroscopic technique. There was only one high affinity site on serum albumin for both the drugs with association constants of the order of 10(4) in the case of cel...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2006.02.008
更新日期:2006-08-01 00:00:00
abstract::Our goal was to establish the requirement of β3 adrenoceptor (β3Adr) for green tea (GT) effects on the energy metabolism of obese mice. This study was carried out in wild-type (WT) and β3Adr knockout (KO) male mice fed with a standard diet or a high-fat diet (HFD/16 weeks) treated or not with GT (0.5 g/kg of body weig...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1016/j.phrs.2020.104956
更新日期:2020-09-01 00:00:00
abstract::Because many Ca2+ channel blocking agents are known to cause adverse systemic effects, in this study we tested the haemodynamic side effects of nimodipine with and without a mild hypoxic-ischaemic (HI) insult in a newborn piglet model. Fifteen min after completing a brief period of asphyxia we gave i.v. nimodipine as ...
journal_title:Pharmacological research
pub_type: 杂志文章
doi:10.1006/phrs.1996.0002
更新日期:1996-01-01 00:00:00
abstract::Fecal microbiota transplant (FMT) has seen a historic emergence in last decade with its sojourn recently entering into a chequered path, due to a few reports of infection and subsequent mortality. Though FMT has been extensively reported, there is no comprehensive report on the delivery routes available for this non-p...
journal_title:Pharmacological research
pub_type: 杂志文章,评审
doi:10.1016/j.phrs.2020.104954
更新日期:2020-09-01 00:00:00
abstract::Erdosteine was introduced in the market as a mucolytic agent for chronic pulmonary diseases more than 10 years ago. The drug contains two blocked sulphydryl groups one of which, after hepatic metabolization and opening of the thiolactone ring, becomes available both for the mucolytic and free radical scavenging and an...
journal_title:Pharmacological research
pub_type: 杂志文章,评审
doi:10.1016/j.phrs.2006.12.006
更新日期:2007-04-01 00:00:00