Evaluation of Physicochemical and Biological Stability of 36-Months-Aged SB5 (Adalimumab Biosimilar) for 4 Weeks at Room Temperature.


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.


Adv Ther


Advances in therapy


Park D,Yun J,Hwang SJ,Park SJ




Has Abstract


2019-02-01 00:00:00














  • Amlodipine/valsartan/hydrochlorothiazide triple combination therapy in moderate/severe hypertension: Secondary analyses evaluating efficacy and safety.

    abstract:INTRODUCTION:An 8-week trial of amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) for moderate or severe hypertension demonstrated more-pronounced blood pressure (BP)-lowering effects compared with dual-component therapies. To elucidate the effects of time and baseline BP on the observed responses, exploratory an...

    journal_title:Advances in therapy

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Calhoun DA,Crikelair NA,Yen J,Glazer RD

    更新日期:2009-11-01 00:00:00

  • Detection of Distant Metastases in Head and Neck Cancer: Changing Landscape.

    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


    authors: de Bree R,Senft A,Coca-Pelaz A,Kowalski L,Lopez F,Mendenhall W,Quer M,Rinaldo A,Shaha AR,Strojan P,Takes RP,Silver CE,Leemans CR,Ferlito A

    更新日期:2018-02-01 00:00:00

  • Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study.

    abstract:INTRODUCTION:The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. METHODS:This observational, prospective, multicenter study included 3152 adults with type 2 ...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Gautier JF,Martinez L,Penfornis A,Eschwège E,Charpentier G,Huret B,Madani S,Gourdy P

    更新日期:2015-09-01 00:00:00

  • A preliminary report on spinal muscular atrophy lymphoblastoid cell lines: are they an appropriate tool for drug screening?

    abstract:INTRODUCTION:Spinal muscular atrophy (SMA) is a neurodegenerative disease of the motor neurons that results in progressive muscle weakness. It is also the leading hereditary cause of infant mortality. Homozygous loss of the survival motor neuron (SMN1) gene causes SMA, and the number of copies of the SMN2 gene modulate...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Dayangaç-Erden D,Topaloğlu H,Erdem-Yurter H

    更新日期:2008-03-01 00:00:00

  • Equally efficacious asthma management with budesonide 800 micrograms administered by Turbuhaler or with beclomethasone dipropionate > or = 1500 micrograms given through a pressurized metered-dose inhaler with spacer. The French Budesonide Trial Group.

    abstract::To avoid the side effects associated with long-term administration of high doses of inhaled glucocorticosteroids, they should be used at the lowest effective dose. This study compared the clinical efficacy of budesonide given via a dry-powder, inspiratory flow-driven device (Turbuhaler), at a daily dose of 800 microgr...

    journal_title:Advances in therapy

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Piquet J,Zuck P,Dennewald G,Dugue P,Grivaux M,Brun P,Severac JC,Ostinelli J,Cheeseman KH

    更新日期:1996-01-01 00:00:00

  • Long-term effects of beraprost sodium on arteriosclerosis obliterans: a single-center retrospective study of Japanese patients.

    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


    authors: Arai T

    更新日期:2013-05-01 00:00:00

  • Nonketotic hyperosmolar coma in a patient with type 1 diabetes-related diabetic nephropathy: case report.

    abstract::Nonketotic hyperosmolar coma (NHC) is characterized by severe hyperglycemia; absence of, or only slight ketosis; nonketotic acidosis; severe dehydration; depressed sensorium or frank coma; and various neurologic signs. This condition is uncommon in type 1 diabetes. Because of little or no osmotic diuresis in patients ...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Dogan E,Erkoc R,Sayarlioglu H,Buyukbese A

    更新日期:2005-09-01 00:00:00

  • Treatment patterns following discontinuation of adalimumab, etanercept, and infliximab in a US managed care sample.

    abstract:OBJECTIVES:Because clinical guidelines do not offer clear recommendations for treatment options after discontinuing a tumor necrosis factor (TNF) blocker, this study evaluated treatment patterns within 360 days after discontinuation of TNF-blocker treatment. METHODS:The IMS LifeLink Health Plan Claims database was use...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Yeaw J,Watson C,Fox KM,Schabert VF,Goodman S,Gandra SR

    更新日期:2014-04-01 00:00:00

  • Plume Characteristics of Two HFA-Driven Inhaled Corticosteroid/Long-Acting Beta2-Agonist Combination Pressurized Metered-Dose Inhalers.

    abstract:INTRODUCTION:New inhalers propelled by hydrofluoroalkanes (HFAs) have improved plume characteristics: higher fine particle fraction, and warmer plumes with reduced force and velocity. Together, this may avoid reflex interruption of inhalation and improve lung deposition of the inhaled drugs. However, even with HFA-prop...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Johal B,Murphy S,Tuohy J,Marshall J

    更新日期:2015-06-01 00:00:00

  • An economic evaluation of budesonide/formoterol for maintenance and reliever treatment in asthma in general practice.

    abstract:INTRODUCTION:In budesonide/formoterol (Symbicort(R) Turbuhaler(R), AstraZeneca, Lund, Sweden) maintenance and reliever therapy (SMART), patients with asthma take a daily maintenance dose of budesonide/formoterol, with the option of taking additional doses for symptom relief instead of a short-acting beta(2)-agonist (SA...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Goossens LM,Riemersma RA,Postma DS,van der Molen T,Rutten-van Mölken MP

    更新日期:2009-09-01 00:00:00

  • Effects of Brinzolamide, a Topical Carbonic Anhydrase Inhibitor, on Corneal Endothelial Cells.

    abstract:INTRODUCTION:This clinical study aimed to investigate the effect of brinzolamide, a topical carbonic anhydrase inhibitor, on corneal endothelial cells (CECs) in patients with glaucoma using a follow-up clinical study design. METHODS:Patients with primary open-angle glaucoma or ocular hypertension were administrated an...

    journal_title:Advances in therapy

    pub_type: 临床试验,杂志文章


    authors: Nakano T,Inoue R,Kimura T,Suzumura H,Tanino T,Yamazaki Y,Yoshikawa K,Tatemichi M

    更新日期:2016-08-01 00:00:00

  • Serum cytokines and bone metabolism in patients with thyroid dysfunction.

    abstract::Hyperthyroidism is associated with increased bone turnover. Besides the hormones of calcium metabolism, locally produced factors are important in maintaining normal bone metabolism. Interleukin-6 (IL-6), in particular, has a major influence on bone turnover. In this study, serum IL-6 and tumor necrosis factor-alpha (T...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Sekeroglu MR,Altun ZB,Algün E,Dülger H,Noyan T,Balaharoglu R,Oztürk M

    更新日期:2006-05-01 00:00:00

  • Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus.

    abstract:INTRODUCTION:The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials. METHODS:Pooled data from 20 trials were analyzed for patients with T2DM treated with emp...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Kinduryte Schorling O,Clark D,Zwiener I,Kaspers S,Lee J,Iliev H

    更新日期:2020-08-01 00:00:00

  • Obstetric outcomes of adolescent pregnancies in Turkey.

    abstract::Pregnancy in adolescence has been and continues to be a problem in public health. The purpose of this study was to investigate obstetric outcomes of adolescent pregnancies in Samsun, Turkey. A cross-sectional study was conducted between January 1 and December 31, 2004, at 3 hospitals in Samsun, Turkey. Of the 10,100 w...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Canbaz S,Sunter AT,Cetinoglu CE,Peksen Y

    更新日期:2005-11-01 00:00:00

  • Consequences of Supraphysiological Dialysate Magnesium on Arterial Stiffness, Hemodynamic Profile, and Endothelial Function in Hemodialysis: A Randomized Crossover Study Followed by a Non-Controlled Follow-Up Phase.

    abstract:INTRODUCTION:Increasing dialysate magnesium (D-Mg2+) appears to be an intriguing strategy to obtain cardiovascular benefits in subjects with end-stage kidney disease (ESKD) on hemodialysis. To date, however, hemodialysis guidelines do not suggest to increase D-Mg2+ routinely set at 0.50 mmol/L. METHODS:A randomized 4-...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Del Giorno R,Lavorato Hadjeres S,Stefanelli K,Allegra G,Zapparoli C,Predrag L,Berwert L,Gabutti L

    更新日期:2020-12-01 00:00:00

  • Cost-effectiveness analysis of lopinavir/ritonavir and atazanavir+ritonavir regimens in the CASTLE study.

    abstract:INTRODUCTION:The purpose of the study was to conduct a cost-effectiveness analysis and budget impact analysis comparing lopinavir with ritonavir (LPV/r) and atazanavir plus ritonavir (ATV+RTV) for antiretroviral-naïve patients with a baseline CD4+ T-cell distribution and total cholesterol (TC) profile as reported in th...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Simpson KN,Rajagopalan R,Dietz B

    更新日期:2009-02-01 00:00:00

  • The Most Severe Stage of Chronic Venous Disease: An Update on the Management of Patients with Venous Leg Ulcers.

    abstract::Venous leg ulcers (VLUs) are the most severe manifestation of chronic venous disease (CVD). Due to their chronic nature, high recurrence rate and slow healing time, VLUs account for 80% of all leg ulcers seen in patients with CVD. VLUs impose a heavy burden on patients that reduces their quality of life; VLUs also rep...

    journal_title:Advances in therapy

    pub_type: 杂志文章,评审


    authors: Nicolaides AN

    更新日期:2020-02-01 00:00:00

  • Clarithromycin suspension vs penicillin V suspension in children with streptococcal pharyngitis.

    abstract::Clarithromycin, an advanced-generation macrolide antibiotic, has demonstrated excellent in vitro activity against group A beta-hemolytic streptococcus (GABHS). Potent activity against Streptococcus pyogenes and a favorable pharmacokinetic profile have made it a reasonable alternative for treatment of patients with str...

    journal_title:Advances in therapy

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: McCarty J,Hedrick JA,Gooch WM

    更新日期:2000-01-01 00:00:00

  • A Map of Racial and Ethnic Disparities in Influenza Vaccine Uptake in the Medicare Fee-for-Service Program.

    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

    pub_type: 杂志文章


    authors: Hall LL,Xu L,Mahmud SM,Puckrein GA,Thommes EW,Chit A

    更新日期:2020-05-01 00:00:00

  • Comparative efficacy of valsartan and olmesartan in mild-to-moderate hypertension: results of 24-hour ambulatory blood pressure monitoring.

    abstract::The aim of this prospective, randomized, open-label, blinded endpoint (PROBE) study was to compare the antihypertensive efficacy of 2 angiotensin II (AII) receptor antagonists with different pharmacologic profiles, valsartan and olmesartan, in patients with mild-to-moderate essential hypertension. After an initial 2-w...

    journal_title:Advances in therapy

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Destro M,Scabrosetti R,Vanasia A,Mugellini A

    更新日期:2005-01-01 00:00:00

  • Ocular trauma in Turkey: a 2-year prospective study.

    abstract::This 2-year prospective study was conducted to identify those at risk for ophthalmologic emergencies, to define the risk factors and reasons for eye injuries, to analyze treatment options, and to compare findings with those of previous studies. A total of 203 patients (74% male, mean age 27.3+/-13.9 y, 51% right eye i...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Oner A,Kekec Z,Karakucuk S,Ikizceli I,Sözüer EM

    更新日期:2006-03-01 00:00:00

  • Drug evaluation: vildagliptin-metformin single-tablet combination.

    abstract::The single-tablet combination of vildagliptin and metformin addresses key defects of type 2 diabetes for improved glycemic control. By inhibiting the dipeptidyl peptidase-4 (DPP-4) enzyme, vildagliptin raises the levels of the active incretin hormones, glucagon-like peptide 1 and glucose-dependent insulinotropic pepti...

    journal_title:Advances in therapy

    pub_type: 杂志文章,评审


    authors: Tahrani AA,Piya MK,Barnett AH

    更新日期:2009-02-01 00:00:00

  • Treatment of hypertension and adherence to treatment guidelines in clinical practice: an Italian study.

    abstract::Despite the results from clinical trials in patients with hypertension and the development of a long list of guidelines for the management of hypertension, many physicians and other healthcare professionals still manage hypertension using approaches that clearly diverge at least partially from the recommendations of t...

    journal_title:Advances in therapy

    pub_type: 共识发展会议,杂志文章,评审


    authors: Malacco E,Ferri C,Grandi AM,Kilama MO,Soglian AG,Vigna L

    更新日期:2005-03-01 00:00:00

  • Cannabis Use in Hospitalized Patients with Chronic Pain.

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    journal_title:Advances in therapy

    pub_type: 杂志文章,评审


    authors: Orhurhu V,Urits I,Olusunmade M,Olayinka A,Salisu Orhurhu M,Uwandu C,Aner M,Ogunsola S,Akpala L,Hirji S,Viswanath O,Karri J,Simopoulos T,Gill J

    更新日期:2020-08-01 00:00:00

  • Evaluation of MRI-US Fusion Technology in Sports-Related Musculoskeletal Injuries.

    abstract:INTRODUCTION:A combination of magnetic resonance imaging (MRI) with real-time high-resolution ultrasound (US) known as fusion imaging may improve visualization of musculoskeletal (MSK) sports medicine injuries. The aim of this study was to evaluate the applicability of MRI-US fusion technology in MSK sports medicine. ...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Wong-On M,Til-Pérez L,Balius R

    更新日期:2015-06-01 00:00:00

  • Modulation of Neuroinflammation in the Central Nervous System: Role of Chemokines and Sphingolipids.

    abstract::Neuroinflammation is a process involved in the pathogenesis of different disorders, both autoimmune, such as neuropsychiatric systemic lupus erythematosus, and degenerative, such as Alzheimer's and Parkinson's disease. In the central nervous system, the local milieu is tightly regulated by different mediators, among w...

    journal_title:Advances in therapy

    pub_type: 杂志文章,评审


    authors: Gualtierotti R,Guarnaccia L,Beretta M,Navone SE,Campanella R,Riboni L,Rampini P,Marfia G

    更新日期:2017-02-01 00:00:00

  • Development of a Framework Based on Reflective MCDA to Support Patient-Clinician Shared Decision-Making: The Case of the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) in the United States.

    abstract:INTRODUCTION:Well- or moderately differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are often slow-growing, and some patients with unresectable, asymptomatic, non-functioning tumors may face the choice between watchful waiting (WW), or somatostatin analogues (SSA) to delay progression. We developed ...

    journal_title:Advances in therapy

    pub_type: 杂志文章


    authors: Wagner M,Samaha D,Khoury H,O'Neil WM,Lavoie L,Bennetts L,Badgley D,Gabriel S,Berthon A,Dolan J,Kulke MH,Goetghebeur M

    更新日期:2018-01-01 00:00:00

  • Correction to: Patterns of Bicalutamide Use in Prostate Cancer Treatment: A U.S. Real-World Analysis Using the SEER-Medicare Database.

    abstract::The original article can be found online. ...

    journal_title:Advances in therapy

    pub_type: 杂志文章,已发布勘误


    authors: Beebe-Dimmer JL,Ruterbusch JJ,Bylsma LC,Gillezeau C,Fryzek J,Schultz NM,Flanders SC,Barlev A,Heath E,Quek RGW

    更新日期:2018-09-01 00:00:00

  • Correction to: Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study.

    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


    authors: Oddone F,Tanga L,Kóthy P,Holló G,VISIONARY Study Group.

    更新日期:2020-08-01 00:00:00

  • Nedocromil sodium ophthalmic solution 2% twice daily in patients with allergic conjunctivitis.

    abstract::In a multicenter, open-label evaluation, 1098 patients with ocular itching and a history of perennial or seasonal allergic conjunctivitis instilled one drop of nedocromil sodium 2% twice daily in each eye. Ocular symptoms, signs, and global improvement were assessed at baseline and 1 month; satisfaction scores, qualit...

    journal_title:Advances in therapy

    pub_type: 临床试验,杂志文章,多中心研究


    authors: Tauber J,Alocril Community Allergy Trial Study Group.

    更新日期:2002-03-01 00:00:00