Abstract:
INTRODUCTION:Tumor necrosis factor (TNF-alpha) inhibitors, such as adalimumab, have shown success in treating autoimmune inflammatory diseases but are associated with substantial financial burdens to the healthcare system. Biosimilars, which are highly similar to biologic agents, offer the potential to reduce the financial burden of treatment. In the case of TNF-alpha inhibitors, they may also offer improved stability and enable prolonged use. SB5, an adalimumab biosimilar, has shown equivalent efficacy and comparable safety to its reference product in clinical trials. Currently, SB5 is approved for storage for 36 months at 2-8 °C and may be stored at room temperature (25 °C) for a maximum period of 14 days. The objective of this study was to evaluate the stability of SB5, aged to its shelf-life of 36 months, at room temperature (25 ± 2 °C) and 60 ± 5% relative humidity (RH) for a period of 4 weeks, which is longer by 14 days than that of SB5 currently approved in the European Union. METHODS:This study evaluated the stability of SB5, aged to its shelf-life of 36 months, at room temperature (25 ± 2 °C) for a period of 4 weeks. Three independent batches of 36 months-aged SB5 were stored at 25 ± 2 °C and 60 ± 5% RH for 4 weeks. Samples were tested at 0, 2, and 4 weeks. RESULTS:Color, clarity, visible particles, pH, protein concentration, and particulate matter were consistent among the batches, and all the test results met the acceptance criteria at each time point. Percent charge variance was maintained over time. Percent of high molecular weight species detected, total purity, relative binding activity by TNF-alpha, and relative potency by TNF-alpha neutralization did not change over time within each batch, and all values were within the acceptance criteria limits. CONCLUSION:SB5 aged for 36 months is physicochemically and biologically stable for 4 weeks at 25 ± 2 °C and 60 ± 5% RH, which is 2 weeks longer than the alternative storage condition as approved by the European Medicines Agency, which is at 25 °C for a period of up to 14 days. FUNDING:Samsung Bioepis Co., Ltd.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Park D,Yun J,Hwang SJ,Park SJdoi
10.1007/s12325-018-0851-5subject
Has Abstractpub_date
2019-02-01 00:00:00pages
442-450issue
2eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-018-0851-5journal_volume
36pub_type
杂志文章abstract::In the original article, the The VISIONARY Study Group Principal Investigator Jose Javier Garcia-Medina. ...
journal_title:Advances in therapy
pub_type: 杂志文章,已发布勘误
doi:10.1007/s12325-020-01407-w
更新日期:2020-08-01 00:00:00
abstract:INTRODUCTION:Most cases of small cell lung cancer (SCLC) are diagnosed at an advanced stage. The objective of this study was to investigate patient characteristics, survival, chemotherapy treatments, and health care use after a diagnosis of advanced SCLC in subjects enrolled in a health system network. METHODS:This wa...
journal_title:Advances in therapy
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abstract::A 54-y-old patient with rheumatoid arthritis (RA) and bilateral lower-limb lymphoedema is presented. Complete decongestive physical therapy (CDP) is the cornerstone of the management programme in all patients suffering from lymphoedema associated with RA, but it is not clear which therapy is the most effective in decr...
journal_title:Advances in therapy
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abstract:INTRODUCTION:Video-assisted thoracic surgery (VATS) lung resections are complex procedures with a critical role played by endoscopic staplers in the transection of vessels, bronchi, and lung tissue. This retrospective, observational study compared hospital resource use, costs, and complications of VATS lobectomy proced...
journal_title:Advances in therapy
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abstract:INTRODUCTION:Patients with chronic kidney disease (CKD) have an increased risk of comorbid conditions, including cardiovascular disease (CVD). Anemia is prevalent in the CKD population and worsens as kidney function declines, resulting in a diminished quality of life and increased morbidity/mortality. The purpose of th...
journal_title:Advances in therapy
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abstract:INTRODUCTION:Despite improved understanding of the risks of influenza and better vaccines for older patients, influenza vaccination rates remain subpar, including in high-risk groups such as older adults, and demonstrate significant racial and ethnic disparities. METHODS:This study considers demographic, clinical, and...
journal_title:Advances in therapy
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journal_title:Advances in therapy
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doi:10.1007/s12325-009-0063-0
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abstract::Adenoid cystic carcinoma (AdCC) of the head and neck is a well-recognized pathologic entity that rarely occurs in the larynx. Although the 5-year locoregional control rates are high, distant metastasis has a tendency to appear more than 5 years post treatment. Because AdCC of the larynx is uncommon, it is difficult to...
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
doi:10.1007/BF02877699
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journal_title:Advances in therapy
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更新日期:2013-06-01 00:00:00
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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:2002-01-01 00:00:00
abstract::Patients with reversible bronchospasm benefit from the use of inhaled beta-adrenergic agents. In this retrospective study of 24 older patients with a variety of conditions associated with reversible bronchospasm--asthma, asthma with emphysema, chronic bronchitis, and asthmatic bronchitis--symptomatic improvement was n...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:
更新日期:1995-05-01 00:00:00
abstract::Retinal vein occlusions are common retinal vascular disorders with the potential for significant vision-related morbidity. Retinal vein occlusions are classified as either branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), or hemiretinal vein occlusion (HRVO) based on the specific occlusion s...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
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更新日期:2011-01-01 00:00:00
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journal_title:Advances in therapy
pub_type: 已发布勘误
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更新日期:2020-02-01 00:00:00
abstract:INTRODUCTION:Infantile hemangiomas (IH) are the most common benign vascular tumors of childhood, with an incidence of 5-10% during the first year of age. Propranolol is considered the first-line treatment for this condition. Potentially there is a high probability of negative results to therapy, because in many countri...
journal_title:Advances in therapy
pub_type: 杂志文章
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更新日期:2016-10-01 00:00:00
abstract:OBJECTIVES:This study set out to examine the efficacy and tolerability of two innovative implant forms of leuprorelin acetate in men with advanced hormone-dependent prostate cancer in everyday clinical practice. METHODS:Data were collected from 818 patients (from 273 centers across Germany) who were pretreated with sl...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0010-y
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abstract:INTRODUCTION:Rhegmatogenous retinal detachment (RRD) with extensive choroidal detachment (CD), suprachoroidal fluid (SCF), and lower intraocular pressure (IOP) markedly increase the difficulty of pars plana vitrectomy (PPV) because it makes the insertion and placement of the trocar cannulas for PPV time-consuming and t...
journal_title:Advances in therapy
pub_type: 杂志文章
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更新日期:2019-01-01 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 ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-014-0175-z
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abstract:BACKGROUND:Previous studies showed the relation of mental distress such as anxiety and depression to coronary vasoconstriction and myocardial ischemia. However, the mental health status of patients suspected to have vasospastic angina is unclear. METHODS:A total of 99 patients underwent intracoronary acetylcholine (AC...
journal_title:Advances in therapy
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journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
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更新日期:2014-06-01 00:00:00
abstract::Permixon, the lipidosterolic extract of Serenoa repens, is widely used for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). This open study assessed the efficacy and tolerability of Permixon 160 mg twice daily administered for 2 years. One hundred fifty-five men with clinically diagnosed B...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1007/BF02853175
更新日期:2002-11-01 00:00:00
abstract::This prospective study was performed to determine whether gentamicin can be prescribed routinely to patients with spinal cord injury undergoing urologic procedures, or whether antibiotic therapy must be selected on the basis of recent urine microbiologic test results. Between January 2004 and June 2005, procedures wer...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章
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更新日期:2006-01-01 00:00:00
abstract::The efficacy and safety of the butterbur leaf extract Ze 339 (carbon dioxide extract from the leaves of Petasites hybridus L., 8 mg petasines per tablet) were tested in patients with seasonal allergic rhinitis. In an open postmarketing surveillance study, 580 patients were treated with an average of 2 tablets of Ze 33...
journal_title:Advances in therapy
pub_type: 杂志文章
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更新日期:2006-03-01 00:00:00
abstract:INTRODUCTION:The Medicare Part D prescription plan has a coverage gap from $2250 to $5100 per year (2006 thresholds) in which patients pay full drug costs (the "donut hole"). We examined prescription costs in patients aged >or=65 years with atrial fibrillation (AF), and the proportions entering/exiting the donut hole i...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-009-0054-1
更新日期:2009-08-01 00:00:00
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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更新日期:2019-04-01 00:00:00
abstract::As head and neck squamous cell carcinoma (HNSCC) patients with distant metastases (DM) were generally treated only palliatively, the value of screening for DM was usually limited to attempts to avoid extensive locoregional treatment when DM were present pretreatment. Recently, the concept of treating oligometastases, ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-018-0662-8
更新日期:2018-02-01 00:00:00
abstract::The extensive use of angiotensin-converting enzyme inhibitors (ACEIs) as antihypertensive agents and the huge amount of data collected in clinical trials and post-marketing studies has allowed the extending of the indication of ACEIs beyond blood pressure control. Current guidelines recommend ACEIs in symptomatic pati...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01455-2
更新日期:2020-10-01 00:00:00
abstract:INTRODUCTION:This study aimed to compare the challenge of puncture and catheterization and the effect of postoperative analgesia of ultrasound-guided continuous thoracic paravertebral block and the continuous epidural analgesia in patients receiving thoracoscopic surgery for lung cancer. METHODS:One-hundred and fifty ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01446-3
更新日期:2020-09-01 00:00:00
abstract:INTRODUCTION:Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. This real-world study evaluated persistence, dose titration, health care resource utilization (HCRU) and associated costs, and medication use among CD patients treated with ustekinumab (UST) in several pooled US commercia...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01276-3
更新日期:2020-05-01 00:00:00
abstract:INTRODUCTION:Intanza® 9 μg (Sanofi Pasteur SA, Lyon, France), a split virion trivalent influenza vaccine delivered by intradermal injection with a microinjection system, became available as a vaccination for adults aged 18 to 59 years old, as of the 2010 southern hemisphere influenza season. METHODS:This study was des...
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