Abstract：
:Biologics embrace a wide range of substances synthesized by cells or living organisms by means of different biological processes, including recombinant DNA technology, controlled gene expression, or antibody technologies. A biosimilar establishes similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exercise. Minimizing development costs and accelerating their market access create a convergence of interests between health services, worried about sustainability, and generic manufacturers. While the demonstration of bioequivalence is sufficient for small synthetic molecules, this approach is not scientifically applicable to a copy of biological drug constituted by large and complex molecules, which are similar but not identical to the originator and are also subject to different post-translational processes. Internists should be confident that the development process of biosimilars ensures a comparable risk-to-benefit balance with the originators. On the basis of available evidence and pharmacovigilance network, there are no grounds to believe that the use of a biosimilar carries more risks for the patient than the use of an originator. Since the first biosimilar was authorized in Europe in 2006, no clinical alerts have raised red flags about the established EMA biosimilar pathway. In this article, we discuss some of the most frequent concerns raised by clinicians about biosimilars and try to explains the scientific principles underlying the biosimilar concept established in the EU in order to license biosimilar drugs.
journal_name
Eur J Intern Medjournal_title
European journal of internal medicineauthors
Pasina L,Casadei G,Nobili Adoi
10.1016/j.ejim.2016.06.005subject
Has Abstractpub_date
2016-09-01 00:00:00pages
28-35eissn
0953-6205issn
1879-0828pii
S0953-6205(16)30174-1journal_volume
33pub_type
杂志文章abstract：BACKGROUND:In discharged patients with heart failure (HF), diverse conditions can intervene to worsen outcome. We would investigate whether such factors present on hospital admission can affect long-term mortality in subjects hospitalized for acute HF. METHODS:One hundred twenty-three consecutive patients hospitalized...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2015.11.029
更新日期：2016-03-01 00:00:00
abstract：:We report a case of Strongyloides stercoralis hyperinfection in a Spanish patient who had never traveled to an endemic area and in whom HIV infection and long-term immunosuppressive treatment most likely contributed to the dissemination of strongyloidiasis. ...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2004.10.002
更新日期：2004-12-01 00:00:00
abstract：:Background: Hyperhomocysteinemia has been accepted as an independent risk factor for atherosclerosis and atherothrombosis. In recent years, several reports have appeared in the literature linking the use of anabolic steroids with acute vascular events in bodybuilders. In this study, we investigated whether hyperhomocy...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/s0953-6205(00)00131-x
更新日期：2001-02-01 00:00:00
abstract：:Background: Ghrelin causes weight gain by increasing food intake in rodents. Tumor necrosis factor alpha (TNFalpha) is produced by adipose tissue, modulates its metabolism and stimulates catabolic processes. The aim of our study was to evaluate whether weight loss treatment modulates serum concentrations of TNFalpha a...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2004.02.002
更新日期：2004-06-01 00:00:00
abstract：BACKGROUND:According to Swiss legislation, do not attempt cardiopulmonary resuscitation (DNACPR) order can be made at any time by patients only, unless the resuscitation is considered as futile, based on the doctors' evaluation. Little is known about how this decision is made, and which are the factors influencing this...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2015.04.003
更新日期：2015-06-01 00:00:00
abstract：INTRODUCTION:Acute admissions to hospital are rising. As a part of a service evaluation we examined pathways of patients following hospital discharge depending on data available on admission to hospital. METHODS:We merged data available on admission to the Wrexham Maelor hospital from an existing data-base in the Acut...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2017.09.029
更新日期：2017-11-01 00:00:00
abstract：OBJECTIVE:The use of commercially available noninvasive markers for chronic hepatitis B (CHB) related fibrosis is not widely available in developing countries so clinicians in those countries frequently use free alternatives. We aimed to create an optimized algorithm for selection of patients with the highest probabili...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2015.07.005
更新日期：2015-10-01 00:00:00
abstract：:Research on multimorbidity has rapidly increased in the last decade, but evidence on the effectiveness of interventions to improve outcomes in patients with multimorbidity is limited. The European Commission is co-funding a large collaborative project named Joint Action on Chronic Diseases and Promoting Healthy Ageing...
journal_title：European journal of internal medicine
pub_type： 杂志文章,评审
doi：10.1016/j.ejim.2015.02.020
更新日期：2015-04-01 00:00:00
abstract：BACKGROUND AND AIM:Chronic kidney disease (CKD) and cardiovascular disease are closely interrelated and the presence of one condition synergistically affects the prognosis of the other, in a negative manner. There are surprisingly very few data on the relationship between baseline coronary artery disease (CAD) severity...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2016.06.031
更新日期：2016-09-01 00:00:00
abstract：BACKGROUND:The optimal revascularization strategy for non-ST elevation acute coronary syndromes (NSTE-ACS) remains controversial, especially in a real world context. The objective of this work was to assess differences at 1 year in all-cause mortality and the composite endpoint of mortality or acute myocardial infarcti...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2006.12.011
更新日期：2007-09-01 00:00:00
abstract：BACKGROUND:Hyperuricemia prognostic impact on clinical outcomes in chronic heart failure (HF) patients has been investigated with inconclusive results. OBJECTIVES:Aim of the study was to evaluate the prognostic impact of serum uric acid (SUA) on long-term clinical outcomes in HF. METHODS:An analysis of MECKI (Metabol...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2019.11.003
更新日期：2020-02-01 00:00:00
abstract：:Background: Impaired gastrointestinal and gallbladder motility, as a complication of long-lasting diabetes mellitus, has been ascribed to the possible development of autonomic neuropathy, although the intervention of hormonal factors may not completely be excluded. In this regard, cholecystokinin (CCK), a gut hormone ...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/s0953-6205(02)00003-1
更新日期：2002-03-01 00:00:00
abstract：:All major antihypertensive drug classes i.e. diuretics, beta-blockers, calcium antagonists and blockers of the renin-angiotensin system have been shown to effectively lower blood pressure and hence to reduce cardiovascular outcomes in hypertensive patients. These drugs decrease cardiovascular complications in hyperten...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2010.08.008
更新日期：2010-12-01 00:00:00
abstract：BACKGROUND:Rheumatoid arthritis (RA) patients have high risk of heart failure (HF). AIMS:Identifying the risk factors and mechanistic pathways associated with HF in patients with RA. METHODS:Cohort study enrolling 355 RA patients. HF was defined according to the ESC criteria. 93 circulating protein-biomarkers (91CVDI...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2020.11.002
更新日期：2020-11-06 00:00:00
abstract：BACKGROUND:There is a lack of information on long term complications of patients with pulmonary embolism (PE), including chronic complaints of dyspnea. METHODS:Consecutive patients with a prior diagnosis of acute PE and an age and gender matched control group with no medical history of PE were presented with a questio...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2008.02.006
更新日期：2008-12-01 00:00:00
abstract：BACKGROUND & AIMS:There is limited data comparing influence of age on the presentation, clinical course, and therapeutic response of patients with ulcerative colitis. We aimed to compare the demographic and clinical characteristics of patients diagnosed with UC in older age vs. adulthood vs. early age. METHODS:Five-hu...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2012.12.014
更新日期：2013-04-01 00:00:00
abstract：BACKGROUND:We aimed to evaluate the presence of nocturnal hypotension (NHP) in ischemic stroke (IS) survivors using ambulatory blood pressure (BP) monitoring (ABPM). METHODS:We included fifty consecutive patients presenting at our outpatient clinic for review and who had been discharged for IS in the previous six mont...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2011.03.004
更新日期：2011-10-01 00:00:00
abstract：AIM:To describe trends in the incidence and outcomes of community-acquired pneumonia (CAP) hospitalizations in Spain (2004-2013). METHODS:We used national hospital discharge data to select all hospital admissions for CAP as primary diagnosis. We analyzed incidence, Charlson comorbidity index (CCI), diagnostic and ther...
journal_title：European journal of internal medicine
pub_type： 杂志文章,多中心研究
doi：10.1016/j.ejim.2016.12.010
更新日期：2017-05-01 00:00:00
abstract：BACKGROUND:In bromocriptine-treated hyperprolactinemic patients with impaired glucose tolerance, metformin was found to reduce plasma levels of prolactin. No previous study has investigated its impact on plasma prolactin in patients with drug-induced hyperprolactinemia. METHODS:The study included 20 women with antipsy...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2016.01.015
更新日期：2016-05-01 00:00:00
abstract：:Inflammatory pseudotumor (IP) is a disorder that constitutes a differential diagnosis of a series of clinical conditions due to a large spectrum of manifestations in presentation since it can involve any organ of the human body. Its basic characteristic is the appearance of inflammatory masses whose symptoms depend on...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2006.03.004
更新日期：2006-11-01 00:00:00
abstract：:Pattern recognition of the long-term disease course before, during, and after pregnancy can provide us with data about the influence of pregnancy on IBD, and vice versa. Determinants that predict an indolent versus an aggressive disease course are currently being sought. Our intention is to analyze the disease course ...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/s0953-6205(00)00088-1
更新日期：2000-08-01 00:00:00
abstract：:A 50-year-old man with no medical history was admitted because of progressive respiratory distress, aseptic meningitis, disseminated intravascular coagulation, cholestatic hepatitis, and renal failure. Mycoplasma pneumoniae infection was confirmed serologically. The patient was treated with erythromycin and showed a f...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/s0953-6205(03)00102-x
更新日期：2003-08-01 00:00:00
abstract：BACKGROUND:Prealbumin is a maker of nutritional status and inflammation of potential prognostic value in acute heart failure (HF). The aim of this study is to evaluate if low prealbumin levels on admission predict mortality and readmissions in patients with acute HF. METHOD:We conducted a prospective observational coh...
journal_title：European journal of internal medicine
pub_type： 杂志文章,多中心研究
doi：10.1016/j.ejim.2017.05.009
更新日期：2017-09-01 00:00:00
abstract：BACKGROUND:Anemia may have important deleterious effects on patients with heart failure. We investigated the presence and causes of anemia among patients admitted because of new-onset congestive heart failure. The prognostic value of anemia was also evaluated. METHODS:We evaluated the presence of anemia, which was def...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2005.11.015
更新日期：2006-05-01 00:00:00
abstract：BACKGROUND:Whether diabetes mellitus (DM) is associated with a higher risk of perioperative mortality and mortality after liver transplantation (LTx) remains unclear. METHODS:We compared the risk of postoperative mortality and morbidity in DM and non-DM patients undergoing LTx. We enrolled 558 DM patients who underwen...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2015.05.010
更新日期：2015-07-01 00:00:00
abstract：:Kingella kingae is an aerobic gram-negative coccobacillus that has been associated predominantly with bone and joint infection but also with septicemia and endocarditis. Until now, only four cases of proven K. kingae meningitis have been reported. We describe a case of a K. kingae meningitis in a male adolescent who p...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/s0953-6205(00)00115-1
更新日期：2000-12-20 00:00:00
abstract：:Background: Hepatopulmonary syndrome (HPS), defined as hypoxemia and functional intrapulmonary right-to-left shunts in the presence of chronic liver disease, is a frequent complication of end-stage liver disease. The aim of this study was to determine the extent of pulmonary dysfunction and the prevalence of HPS in no...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/s0953-6205(02)00066-3
更新日期：2002-08-01 00:00:00
abstract：BACKGROUND:chronic viral infections by both HCV and HIV may lead to polyclonal activation of B cells resulting in hypergammaglobulinemia. This study retrospectively analyzed the effect of HCV eradication with interferon-free direct-acting antiviral agents (DAAs) on the gamma globulin levels in HCV-infected patients wit...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2020.01.006
更新日期：2020-05-01 00:00:00
abstract：:Coeliac disease is a common disorder. Due to the protean manifestations of the disease and the often mild but indolent course, the diagnosis is often missed. The method to diagnose this in principle reversible disease after the introduction of a gluten-free diet has attracted the attention of several scientific discip...
journal_title：European journal of internal medicine
pub_type： 杂志文章,评审
doi：10.1016/j.ejim.2010.01.015
更新日期：2010-08-01 00:00:00
abstract：BACKGROUND:Diagnostic algorithms for pulmonary embolism (PE) have been validated in patients attending hospital emergency departments. However, general practitioners (GPs) are often the professionals of first resort for the majority of non-critical cases of PE. AIM:To evaluate the knowledge of the diagnostic algorithm...
journal_title：European journal of internal medicine
pub_type： 杂志文章
doi：10.1016/j.ejim.2014.11.005
更新日期：2015-01-01 00:00:00
