Abstract:
:With the increasing availability of biosimilars, the practice of switching therapies for non-medical reasons between an originator biologic and an analogous biosimilar has become more common. The evidence to support this practice mostly comes from single-switch randomized controlled trials (RCTs) and real-world (RW) evidence studies. However, as more biosimilars of the same originator enter the market, multiple switching events between originators and biosimilars is becoming a reality, despite limited evidence to support the efficacy and safety of such practice. Some countries have established guidelines, policies, or laws related to interchangeability and/or automatic substitution, whereas others have left these practices unregulated or controlled by other components of the healthcare system. Collectively, guidelines on single non-medical switching are often vague, with even less focus given to multiple non-medical switching, leaving this practice mostly unregulated. This narrative review will first discuss the current regulatory perspectives on non-medical switching and challenges associated with switching therapies, particularly with the availability of multiple biosimilars. We will then review the current evidence from RCTs and RW studies in the light of three different multiple-switch scenarios currently taking place in clinical practice: switching between an originator and a single biosimilar, switching between biosimilars of the same originator, and the clinical practice of switching back to the originator (i.e., switchbacks) after a failure of the initial non-medical switch to the analogous biosimilar.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Feagan BG,Marabani M,Wu JJ,Faccin F,Spronk C,Castañeda-Hernández Gdoi
10.1007/s12325-020-01472-1subject
Has Abstractpub_date
2020-11-01 00:00:00pages
4491-4518issue
11eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-020-01472-1journal_volume
37pub_type
杂志文章,评审abstract::The prognosis for patients with rheumatoid arthritis or spondyloarthritides has improved dramatically due to earlier diagnosis, recognition of the need to treat early with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), alone or in combinations, the establishment of treatment targets, and the ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-014-0142-8
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abstract:INTRODUCTION:This study characterized the multidose pharmacokinetic (PK) characteristics of posaconazole tablets used as prophylactic antifungal therapy in Chinese patients with acute myelogenous leukemia (AML) at risk for invasive fungal infection (IFI). METHODS:Participants in this open-label, single-arm, phase 1b s...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
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abstract:INTRODUCTION:Ivabradine has opened up new possibilities for treating stable angina and chronic heart failure by lowering heart rate. Ivabradine lowers heart rate by selectively inhibiting the I f current in the sinoatrial node. This study aimed to determine whether the decrease in heart rate achieved with ivabradine wa...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章
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abstract::Angio-immunoblastic T-cell lymphoma (AITL), a rare disease that constitutes 1% to 2% of non-Hodgkin's lymphomas, presents in middle-aged and elderly individuals. This report describes a patient with high-grade fever and lymphadenopathy. An extensive in-hospital work-up that included lymph node biopsy yielded negative ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849974
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abstract::Diabetic foot ulcers (DFUs) are one of the most common and serious complications of diabetes mellitus, as wound healing is impaired in the diabetic foot. Wound healing is a dynamic and complex biological process that can be divided into four partly overlapping phases: hemostasis, inflammation, proliferative and remode...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-014-0140-x
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abstract::Obesity is increasing in epidemic proportions globally while current therapies continue to be suboptimal. In this investigation, weight loss in obese individuals after 24 weeks with different nutrition interventions was compared. The impact of intervention intensity was assessed. Inclusion criteria were established an...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析,评审
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abstract:INTRODUCTION:Fixed-combination intraocular pressure (IOP)-lowering medications simplify treatment regimens for patients requiring 2 ocular hypotensive agents to maintain sufficiently low IOP. The aim of this study was to evaluate the safety and efficacy of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) versu...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2014-12-01 00:00:00
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journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01352-8
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pub_type: 杂志文章,评审
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journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2001-07-01 00:00:00
abstract:INTRODUCTION:The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data. The objective was to identify whether the use of passive surveillance or active surveillance provides diff...
journal_title:Advances in therapy
pub_type: 杂志文章
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journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850133
更新日期:2006-03-01 00:00:00
abstract::Available data from comparative trials involving 483 patients were analyzed to determine the rate of infectious morbidity following the use of absorbable staples versus traditional incision and suturing of the vaginal cuff in abdominal hysterectomy. Infections occurred in 24 of 268 (9%) patients who received absorbab...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:
更新日期:1991-05-01 00:00:00
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journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-011-0042-0
更新日期:2011-08-01 00:00:00
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journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0010-y
更新日期:2013-03-01 00:00:00
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journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849991
更新日期:2007-01-01 00:00:00
abstract::Low- and middle-income countries (LMICs) are challenged with a disproportionately high burden of noncommunicable diseases (NCDs) and limited healthcare resources at their disposal to tackle the NCD epidemic. Understanding the patient journey for NCDs from the patients' perspective can help healthcare systems in these ...
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pub_type: 杂志文章,评审
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abstract::The improvement of glycemic control in patients with type 2 diabetes (T2D) is an urgent need in Asia. East Asian T2D patients have distinct characteristics, including relatively low body weight, early impairment of islet beta cell function with reduced insulin secretion and a marked increase in postprandial blood gluc...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
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journal_title:Advances in therapy
pub_type: 杂志文章,评审
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journal_title:Advances in therapy
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journal_title:Advances in therapy
pub_type: 杂志文章
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abstract::Human papillomavirus (HPV) infection is one of the most common sexually transmitted infections in adolescents. Such infection is associated with substantial health risks and is unpredictable in its resolution. Genital warts are the most common clinical manifestations of genital HPV infections. Most genital warts are c...
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pub_type: 杂志文章,评审
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journal_title:Advances in therapy
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更新日期:2009-08-01 00:00:00
abstract::There has been increased interest in gout in both academic and clinical practice settings. Several reasons may explain this. The prevalence of both hyperuricemia and gout has risen in the last decades in developed countries and therefore the burden of gout has increased. The association of hyperuricemia and gout with ...
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pub_type: 杂志文章,评审
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abstract:INTRODUCTION:Arteriosclerosis obliterans (ASO) causes ischemic symptoms of the lower limbs, reducing quality of life (QOL), and has a poor prognosis. Early diagnosis and treatment are necessary. In this study, the effects of long-term administration of beraprost sodium (beraprost) to treat ASO were investigated. METHO...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0030-7
更新日期:2013-05-01 00:00:00
abstract:INTRODUCTION:The long-term safety of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS) has been studied in mainly Caucasian patients. The present interim analysis aimed to evaluate the 72-week safety of DMF in Japanese patients with RRMS. METHODS:Safety data of Japanese subjects en...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-018-0788-8
更新日期:2018-10-01 00:00:00
abstract:BACKGROUND:Mutation of human receptor tyrosine kinase epidermal growth factor receptor-2 (HER2) is a rare event, found in approximately 1% non-small cell lung cancers (NSCLC). The objective was to investigate the clinical characteristics and management of HER2-mutated NSCLCs in a real-life setting. METHODS:This multic...
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pub_type: 杂志文章
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更新日期:2019-08-01 00:00:00
abstract::Patients with acute myeloid leukemia (AML) with the t(8;21) karyotype generally have a favorable clinical course, but key prognostic factors remain poorly defined. This study was conducted to determine the prognoses and treatment outcomes of patients with AML with this unique cytogenetic change. A total of 22 patients...
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pub_type: 杂志文章
doi:10.1007/BF02849984
更新日期:2007-07-01 00:00:00
abstract::Blood pressure lowering by all classes of antihypertensive drugs is accompanied by significant reductions of stroke and major cardiovascular (CV) events. Drugs acting on the renin-angiotensin-aldosterone system, such as angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), showed s...
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pub_type: 杂志文章,评审
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更新日期:2019-02-01 00:00:00