The emergence of biosimilar insulin preparations--a cause for concern?

Abstract:

:Several biopharmaceuticals, including insulin and insulin analogs, are, or shortly will be, off-patent, thereby providing an opportunity for companies to attempt to manufacture "copies" commonly referred to as biosimilars and also known as follow-on biologics. Reassurance that such copy biologics are equally safe and effective as the conventional products is essential. It is important for the clinician to consider what information is therefore necessary for such assurances. Biopharmaceuticals, produced from living organisms and manufactured by complex processes, differ in many respects from chemically derived drugs. The biological source materials and manufacturing processes for non-innovator biologics may differ considerably from those used for producing the innovator substance. Differences between innovator and non-innovator products can be identified analytically (e.g., batch-to-batch consistency, product stability along side clinical safety). This provides a strong argument for caution before automatic substitution of conventional products (e.g., insulin by biosimilars). Several non-innovator insulins, including insulin analogs (while still patent-protected), are already available in many countries. Many of these lack rigorous regulations for biosimilar approval and pharmacovigilance. Recently an application for a biosimilar recombinant human insulin was withdrawn by the European Medicines Agency because of safety and efficacy concerns. Therefore, every biosimilar insulin and insulin analog should be assessed by well-defined globally harmonized preclinical and clinical studies followed by post-marketing pharmacovigilance programs, in the interest of people with diabetes worldwide.

journal_name

Diabetes Technol Ther

authors

Owens DR,Landgraf W,Schmidt A,Bretzel RG,Kuhlmann MK

doi

10.1089/dia.2012.0105

subject

Has Abstract

pub_date

2012-11-01 00:00:00

pages

989-96

issue

11

eissn

1520-9156

issn

1557-8593

journal_volume

14

pub_type

杂志文章,评审
  • Lipoprotein-associated phospholipase A₂ activity predicts progression of subclinical coronary atherosclerosis.

    abstract:BACKGROUND:Lipoprotein-associated phospholipase A₂ (Lp-PLA₂) is a lipoprotein-associated enzyme that cleaves oxidized phosphatidylcholines, generating pro-atherosclerotic lysophosphatidylcholine and oxidized free fatty acids. Lp-PLA₂ is independently associated with cardiovascular disease (CVD) in a variety of populati...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2010.0175

    authors: Kinney GL,Snell-Bergeon JK,Maahs DM,Eckel RH,Ehrlich J,Rewers M,Hokanson JE

    更新日期:2011-03-01 00:00:00

  • A pilot study of the SPRINT protocol for tight glycemic control in critically Ill patients.

    abstract:BACKGROUND:Stress-induced hyperglycemia is prevalent in critical care, even in patients with no history of diabetes. Increased counter-regulatory hormone response increases gluconeogenesis and effective insulin resistance, which can be exacerbated by drug therapy. Control of blood glucose levels to the 4.0-6.1 mmol/L r...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2006.8.449

    authors: Lonergan T,Compte AL,Willacy M,Chase JG,Shaw GM,Hann CE,Lotz T,Lin J,Wong XW

    更新日期:2006-08-01 00:00:00

  • Venous, Arterialized-Venous, or Capillary Glucose Reference Measurements for the Accuracy Assessment of a Continuous Glucose Monitoring System.

    abstract:BACKGROUND:Different reference methods are used for the accuracy assessment of continuous glucose monitoring (CGM) systems. The effect of using venous, arterialized-venous, or capillary reference measurements on CGM accuracy is unclear. METHODS:We evaluated 21 individuals with type 1 diabetes using a capillary calibra...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1089/dia.2017.0189

    authors: Kropff J,van Steen SC,deGraaff P,Chan MW,van Amstel RBE,DeVries JH

    更新日期:2017-11-01 00:00:00

  • Impact of glycemic control on heart rate variability in youth with type 1 diabetes: the SEARCH CVD study.

    abstract:AIM:This study explored the role of glycemic control on cardiac autonomic function, measured by heart rate variability (HRV), in youth with type 1 diabetes. PATIENTS AND METHODS:A retrospective cohort of 345 youth with type 1 diabetes (mean age, 18.5 years; duration, 10 years) participating in the SEARCH for Diabetes ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,多中心研究

    doi:10.1089/dia.2013.0147

    authors: Jaiswal M,Fingerlin TE,Urbina EM,Wadwa RP,Talton JW,D'Agostino RB Jr,Hamman RF,Daniels SR,Marcovina SM,Dolan LM,Dabelea D

    更新日期:2013-12-01 00:00:00

  • Oral Semaglutide: A Review of the First Oral Glucagon-Like Peptide 1 Receptor Agonist.

    abstract::Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are highly effective at lowering hemoglobin A1c (HbA1c) and facilitating weight loss. Four agents in the GLP-1 RA class, albiglutide, liraglutide, dulaglutide, and semaglutide, also have cardioprotective effects. However, subcutaneous administration of these agents...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,评审

    doi:10.1089/dia.2019.0185

    authors: Bucheit JD,Pamulapati LG,Carter N,Malloy K,Dixon DL,Sisson EM

    更新日期:2020-01-01 00:00:00

  • Intervention trials for prevention of metabolic syndrome and type 2 diabetes: focus on Asian Indians.

    abstract::Prevalence of diabetes continues to increase in urban areas, and escalation is discernible in semi-urban and rural areas. It is reported to affect Asian Indians a decade earlier compared with other populations, and complications (e.g., nephropathy) occur earlier and are severe and more prevalent than in other races. B...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,评审

    doi:10.1089/dia.2013.0373

    authors: Shrivastava U,Misra A

    更新日期:2014-08-01 00:00:00

  • Role of continuous subcutaneous insulin infusion in patients with recalcitrant diabetes in South India.

    abstract:BACKGROUND:We aimed to assess the effect of continuous subcutaneous insulin infusion (CSII) therapy in patients with "recalcitrant diabetes" whose glycemia had not been controlled adequately with multiple daily injections of insulin or insulin plus oral hypoglycemic agents. PATIENTS AND METHODS:We retrospectively anal...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2009.0066

    authors: Sudhakaran C,Anjana RM,Rao K,Unnikrishnan R 1st,Suresh T,Mohan V

    更新日期:2009-11-01 00:00:00

  • Feasibility of a portable bihormonal closed-loop system to control glucose excursions at home under free-living conditions for 48 hours.

    abstract:BACKGROUND:This study assessed the feasibility of a portable bihormonal closed-loop system at home. SUBJECTS AND METHODS:Sixteen pump-treated patients with type 1 diabetes received 48 h of closed-loop therapy with a telemonitored insulin- and glucagon-delivering closed-loop system and 48 h of patient-managed open-loop...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2013.0166

    authors: van Bon AC,Luijf YM,Koebrugge R,Koops R,Hoekstra JB,DeVries JH

    更新日期:2014-03-01 00:00:00

  • Metrics to Evaluate Quality of Glycemic Control: Comparison of Time in Target, Hypoglycemic, and Hyperglycemic Ranges with "Risk Indices".

    abstract:OBJECTIVE:We sought to cross validate several metrics for quality of glycemic control, hypoglycemia, and hyperglycemia. RESEARCH DESIGN AND METHODS:We analyzed the mathematical properties of several metrics for overall glycemic control, and for hypo- and hyperglycemia, to evaluate their similarities, differences, and ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2017.0416

    authors: Rodbard D

    更新日期:2018-05-01 00:00:00

  • Lipohypertrophy in China: Prevalence, Risk Factors, Insulin Consumption, and Clinical Impact.

    abstract:BACKGROUND:Lipohypertrophy (LH) is a complication of insulin therapy. We assessed LH prevalence, risk factors, insulin usage, and clinical and health economic effects in China. METHODS:In four cities, 401 adult patients injecting insulin ≥1 year were surveyed for diabetes/insulin injection history and practices, pen n...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2016.0334

    authors: Ji L,Sun Z,Li Q,Qin G,Wei Z,Liu J,Chandran AB,Hirsch LJ

    更新日期:2017-01-01 00:00:00

  • Accuracy and reliability of continuous glucose monitoring systems: a head-to-head comparison.

    abstract:OBJECTIVE:This study assessed the accuracy and reliability of three continuous glucose monitoring (CGM) systems. RESEARCH DESIGN AND METHODS:We studied the Animas® (West Chester, PA) Vibe™ with Dexcom® (San Diego, CA) G4™ version A sensor (G4A), the Abbott Diabetes Care (Alameda, CA) Freestyle® Navigator I (NAV), and ...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1089/dia.2013.0049

    authors: Luijf YM,Mader JK,Doll W,Pieber T,Farret A,Place J,Renard E,Bruttomesso D,Filippi A,Avogaro A,Arnolds S,Benesch C,Heinemann L,DeVries JH,AP@home consortium.

    更新日期:2013-08-01 00:00:00

  • Neural network-based real-time prediction of glucose in patients with insulin-dependent diabetes.

    abstract:BACKGROUND:Continuous glucose monitoring (CGM) technologies report measurements of interstitial glucose concentration every 5 min. CGM technologies have the potential to be utilized for prediction of prospective glucose concentrations with subsequent optimization of glycemic control. This article outlines a feed-forwar...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2010.0104

    authors: Pappada SM,Cameron BD,Rosman PM,Bourey RE,Papadimos TJ,Olorunto W,Borst MJ

    更新日期:2011-02-01 00:00:00

  • Enzymatic fluorescent microsphere glucose sensors:evaluation of response under dynamic conditions.

    abstract::Most previous attempts at the development of a "smart tattoo" for glucose monitoring in diabetes--implantable fluorescent microspheres that can be implanted intradermally and interrogated transdermally using light--have focused on the encapsulation of a competitive binding assay for glucose within hydrogel microsphere...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2006.8.288

    authors: Brown JQ,Srivastava R,Zhu H,McShane MJ

    更新日期:2006-06-01 00:00:00

  • A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.

    abstract:BACKGROUND:Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHODS:PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,多中心研究

    doi:10.1089/dia.2017.0142

    authors: Christiansen MP,Klaff LJ,Brazg R,Chang AR,Levy CJ,Lam D,Denham DS,Atiee G,Bode BW,Walters SJ,Kelley L,Bailey TS

    更新日期:2018-03-01 00:00:00

  • Determining clinical and psychological benefits and barriers with continuous glucose monitoring therapy.

    abstract:BACKGROUND:Preventing the complications of diabetes requires tight control and minimizing blood glucose fluctuation. Pursuing these goals increases the risk of severe hypoglycemia. The authors hoped to identify if using continuous glucose monitoring (CGM) decreased the incidence of severe hypoglycemia, resulted in less...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2009.0121

    authors: Halford J,Harris C

    更新日期:2010-03-01 00:00:00

  • Factors Affecting Recruitment of Participants for Studies of Diabetes Technology in Newly Diagnosed Youth with Type 1 Diabetes: A Qualitative Focus Group Study with Parents and Children.

    abstract:BACKGROUND:Relatively little is known about parents' or children's attitudes toward recruitment for, and participation in, studies of new diabetes technologies immediately after diagnosis. This study investigated factors affecting recruitment of participants for studies in newly diagnosed youth with type 1 diabetes. M...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2016.0157

    authors: Farrington C,Allen J,Tauschmann M,Randell T,Trevelyan N,Hovorka R

    更新日期:2016-09-01 00:00:00

  • Reduction in hemoglobin A1C with real-time continuous glucose monitoring: results from a 12-week observational study.

    abstract:BACKGROUND:Real-time continuous glucose monitoring (CGM) was studied in 140 adults with diabetes over a 12-week period of home use. Hemoglobin A(1c)(HbA1c) was measured on day 1 (baseline) and at weeks 6 and 12. METHODS:On day 1, participants received the CGM device (STS(R) System, DexCom, Inc., San Diego, CA) and und...

    journal_title:Diabetes technology & therapeutics

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1089/dia.2007.0205

    authors: Bailey TS,Zisser HC,Garg SK

    更新日期:2007-06-01 00:00:00

  • ROSSO-in-praxi: a self-monitoring of blood glucose-structured 12-week lifestyle intervention significantly improves glucometabolic control of patients with type 2 diabetes mellitus.

    abstract:BACKGROUND:As healthy diet and physical activity can improve glucometabolic control in patients with type 2 diabetes, lifestyle changes should be the basis for each therapy. The only tool to visualize immediate effects of food pattern and exercise on blood glucose levels is self-monitoring of blood glucose (SMBG). Ther...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2010.0008

    authors: Kempf K,Kruse J,Martin S

    更新日期:2010-07-01 00:00:00

  • Continuous glucose monitoring in patients undergoing cardiac surgery.

    abstract:OBJECTIVES:Hyperglycemia is a prominent feature among patients exposed to major stress such as in cardiac surgery. The implementation of a continuous glucose monitoring system (CGMS) for glucose monitoring during cardiac surgery was assessed. SUBJECTS AND METHODS:Fifty-nine consecutive patients who underwent cardiac s...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2011.0154

    authors: Kalmovich B,Bar-Dayan Y,Boaz M,Wainstein J

    更新日期:2012-03-01 00:00:00

  • Minimally invasive insulin delivery in subjects with type 1 diabetes using hollow microneedles.

    abstract:BACKGROUND:Microneedles have previously been used to deliver insulin to animal models, but not in human subjects. This study tested the hypothesis that hollow microneedles can deliver insulin to modulate blood glucose levels in subjects with type 1 diabetes in a minimally invasive manner. METHODS:This study was carrie...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2008.0103

    authors: Gupta J,Felner EI,Prausnitz MR

    更新日期:2009-06-01 00:00:00

  • Patient perceptions of using the OmniPod system compared with conventional insulin pumps in young adults with type 1 diabetes.

    abstract:AIMS:This study evaluated treatment satisfaction, comfort, and function using the wireless OmniPod™ Insulin Management System (Insulet Corp., Bedford, MA) compared with conventional (infusion set) insulin pumps in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS:Twenty-nine patients (age, 24.0 ± 5.1 year...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1089/dia.2011.0228

    authors: Lebenthal Y,Lazar L,Benzaquen H,Shalitin S,Phillip M

    更新日期:2012-05-01 00:00:00

  • Association of DRD3, COMT, and SLC6A4 Gene Polymorphisms with Type 2 Diabetes in Southern Chinese: A Hospital-Based Case-Control Study.

    abstract:AIM:The aim of this study was to assess the associations of six single nucleotide polymorphisms (SNPs) of three genes (DRD3, COMT, and SCL6A4) with type 2 diabetes mellitus (T2DM) in Southern Chinese. SUBJECTS AND METHODS:Five hundred ninety-five cases with T2DM and 725 healthy controls of Han origin were recruited fr...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2014.0344

    authors: Xiu L,Lin M,Liu W,Kong D,Liu Z,Zhang Y,Ouyang P,Liang Y,Zhong S,Chen C,Jin X,Fan X,Qin J,Zhao X,Rao S,Ding Y

    更新日期:2015-08-01 00:00:00

  • Insulin Pump Settings During Breastfeeding in Women with Type 1 Diabetes.

    abstract:: Background: We aimed to explore insulin pump settings in breastfeeding women with type 1 diabetes. Methods: Thirteen unselected breastfeeding women with type 1 diabetes on insulin pump therapy were included consecutively from A...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2019.0280

    authors: Nørgaard SK,Nørgaard K,Roskjær AB,Mathiesen ER,Ringholm L

    更新日期:2020-04-01 00:00:00

  • Nutritional influences on inflammation and type 2 diabetes risk.

    abstract::There is a clear role for inflammation in the development of type 2 diabetes and its associated co-morbidities. Circulating inflammatory markers such as C-reactive protein, sialic acid, and interleukin- 6 are all significant independent predictors of disease. A number of nutritional components are hypothesized to modu...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,评审

    doi:10.1089/dia.2006.8.45

    authors: Browning LM,Jebb SA

    更新日期:2006-02-01 00:00:00

  • Is the masked continuous glucose monitoring system clinically useful for predicting hemoglobin A1C in type 1 diabetes?

    abstract:BACKGROUND:The masked continuous glucose monitoring system (Masked-CGMS) differs from standard CGMSs in three ways: (1) there is no feedback to the user so that no immediate regimen changes can be made; (2) it can only be worn for up to 5 days; and (3) there are no alarms to warn of hyperglycemia or hypoglycemia. Since...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2013.0297

    authors: Duran-Valdez E,Burge MR,Broderick P,Shey L,Valentine V,Schrader R,Schade DS

    更新日期:2014-05-01 00:00:00

  • Continuous glucose monitoring pilot in low-income type 1 diabetes patients.

    abstract:BACKGROUND:Continuous glucose monitoring (CGM) has been shown to be a valuable tool to improve glycemic control in patients with diabetes. The objective of this pilot study was to develop and implement CGM in an existing diabetes clinic for low-income patients on multiple daily injections. SUBJECTS AND METHODS:This wa...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1089/dia.2013.0072

    authors: Sequeira PA,Montoya L,Ruelas V,Xing D,Chen V,Beck R,Peters AL

    更新日期:2013-10-01 00:00:00

  • Randomized Evaluation of Glycemic Control in the Medical Intensive Care Unit Using Real-Time Continuous Glucose Monitoring (REGIMEN Trial).

    abstract:BACKGROUND AND OBJECTIVE:Hyperglycemia occurs commonly in patients admitted to medical intensive care units (MICUs). Whether real-time (RT) continuous glucose monitoring (CGM) improves glycemic control and variability and reduces hypoglycemia in severely ill MICU patients with an Acute Physiology and Chronic Health Eva...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1089/dia.2015.0151

    authors: De Block CE,Gios J,Verheyen N,Manuel-y-Keenoy B,Rogiers P,Jorens PG,Scuffi C,Van Gaal LF

    更新日期:2015-12-01 00:00:00

  • Overcoming skin's barrier: the search for effective and user-friendly drug delivery.

    abstract::Although hypodermic needles rapidly deliver large doses of drugs such as insulin across the skin for systemic administration, the pain, local trauma, and difficulty to achieve sustained or complex delivery profiles has motivated development of novel alternative technologies. Microneedles, jet injectors, and thermal po...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,评审

    doi:10.1089/152091501300209606

    authors: Prausnitz MR

    更新日期:2001-07-01 00:00:00

  • Evaluation of the Adherence to Continuous Glucose Monitoring in the Management of Type 1 Diabetes Patients on Sensor-Augmented Pump Therapy: The SENLOCOR Study.

    abstract:BACKGROUND:Continuous glucose monitoring (CGM) and sensor-augmented pump (SAP) therapy improve glucose control provided good adherence. In France, not only diabetologists, nurses, and dieticians but also nurses employed by homecare providers (HCPNs) are together involved in the initiation and/or follow-up of continuous...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章,多中心研究

    doi:10.1089/dia.2015.0240

    authors: Picard S,Hanaire H,Baillot-Rudoni S,Gilbert-Bonnemaison E,Not D,Reznik Y,Guerci B

    更新日期:2016-03-01 00:00:00

  • Differences in exhaled gas profiles between patients with type 2 diabetes and healthy controls.

    abstract:AIMS:Recent advances in analytical technology allow the detection of several hundred volatile organic compounds (VOCs) in human exhaled air, many of which reflect unidentified endogenous pathways. This study was performed to determine whether a breath gas analysis using proton transfer reaction-mass spectrometry (PTR-M...

    journal_title:Diabetes technology & therapeutics

    pub_type: 杂志文章

    doi:10.1089/dia.2009.0181

    authors: Greiter MB,Keck L,Siegmund T,Hoeschen C,Oeh U,Paretzke HG

    更新日期:2010-06-01 00:00:00