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https://www.readbyqxmd.com/read/29668697/efficacy-and-safety-of-biosimilar-insulins-compared-to-their-reference-products-a-systematic-review
#1
Carolyn Tieu, Eleanor J Lucas, Mindi DePaola, Lori Rosman, G Caleb Alexander
IMPORTANCE: For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017. OBJECTIVE: To summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products. DATA SOURCES: We conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and IndiaMED from their inception through January 14, 2018...
2018: PloS One
https://www.readbyqxmd.com/read/29656504/efficacy-and-safety-of-myl-1501d-vs-insulin-glargine-in-patients-with-type-1-diabetes-after-52-weeks-results-of-the-instride-1-phase-iii-study
#2
Thomas C Blevins, Abhijit Barve, Bin Sun, Michael Ankersen
AIM: To test the safety and efficacy of MYL-1501D, a proposed insulin glargine biosimilar, in patients with type 1 diabetes mellitus (T1DM). METHODS: The safety and efficacy of MYL-1501D and reference insulin glargine were evaluated in INSTRIDE 1, a 52-week, open-label, randomized, phase III study in patients with T1DM. The primary objective was to determine whether once-daily MYL-1501D was non-inferior to once-daily insulin glargine when administered in combination with mealtime insulin lispro based on change in glycated haemoglobin (HbA1c) from baseline to week 24...
April 15, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29575724/a-cross-sectional-survey-of-biosimilar-insulin-utilisation-in-asia-the-joint-asia-diabetes-evaluation-jade-programme
#3
Linsey Gani, Eric Lau, Andrea Luk, Leorino Sobrepena, Tran Quang Khanh, Jothydev Kesavadev, Weiping Jia, Weinan Yu, Chiu Chi Tsang, Mukhopadhyay Monojitketan, Sujeet Jha, Wayne Sheu, Kun Ho Yoon, Thy Khue Nguyen, Risa Ozaki, Wing Yee So, Christine Kwan, Amy W C Fu, Roberto Mirasol, Sanjeev Ratnakar Phatak, K M Prasanna Kumar, S R Aravind, Hari Janakiraman, Juliana Cn Chan
BACKGROUND: Biosimilar insulin may reduce treatment costs although its extent of usage is largely unknown. We examined biosimilar insulin use and its associations with quality of glycemic control using the JADE (Joint Asia Diabetes Evaluation) Register. METHODS: We conducted a cross-sectional analysis in 81,531 patients with type 1 and type 2 diabetes enrolled into the JADE Programme from 2007 to 2014. We extracted all insulin-related terms from the JADE portal and compared clinical profiles between biosimilar and originator insulin users...
March 25, 2018: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/29536603/biosimilar-vs-originator-insulins-systematic-review-and-meta-analysis
#4
Tomohide Yamada, Ryuichi Kamata, Kotomi Ishinohachi, Nobuhiro Shojima, Sophia Ananiadou, Hisashi Nom, Toshimasa Yamauchi, Takashi Kadowaki
Biosimilar insulins have expanded the treatment options for diabetes. We compared the clinical efficacy and safety of biosimilar insulins with those of originator insulins by conducting a meta-analysis. A random-effects meta-analysis was performed on randomized controlled trials comparing biosimilar and originator insulins in adults with diabetes. Studies were obtained by searching electronic databases up to December 2017. Ten trials, in a total of 4935 patients, were assessed (2 trials each on LY2963016, MK-1293, Mylan's insulin glargine and SAR342434, and 1 trial each on FFP-112 and Basalog)...
March 14, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29368288/ly2963016-insulin-glargine-a-review-in-type-1-and-2-diabetes
#5
Yvette N Lamb, Yahiya Y Syed
Subcutaneous once-daily LY2963016 insulin glargine (LY insulin glargine) [Abasaglar® (EU); Basaglar® (USA)] has been approved in the EU as a biosimilar to reference insulin glargine (Lantus®), and in the USA as a follow-on biologic to reference insulin glargine, for use in patients with type 1 or 2 diabetes. Structural and functional characterization of LY insulin glargine in preclinical studies showed that it is similar to reference insulin glargine. In phase I euglycaemic clamp studies, LY insulin glargine demonstrated similar pharmacodynamic (including duration of action) and pharmacokinetic parameters to reference insulin glargine...
January 24, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29359575/safety-of-insulin-lispro-and-a-biosimilar-insulin-lispro-when-administered-through-an-insulin-pump
#6
James Thrasher, Howard Surks, Irene Nowotny, Suzanne Pierre, Baerbel Rotthaeuser, Karin Wernicke-Panten, Satish Garg
BACKGROUND: SAR342434 (U100; SAR-Lis; insulin lispro) is a biosimilar/follow-on to insulin lispro (U100; Ly-Lis). Similar pharmacokinetics/pharmacodynamics between the two products has been demonstrated in a hyperinsulinemic euglycemic clamp study. The current study evaluated the safety of SAR-Lis and Ly-Lis when administered by continuous subcutaneous insulin infusion (CSII; insulin pumps). METHODS: This was a randomized, open-label, 2 × 4-week, two-arm crossover study in 27 patients with type 1 diabetes mellitus (NCT02603510)...
January 1, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/29355435/anti-insulin-antibodies-and-adverse-events-with-biosimilar-insulin-lispro-compared-with-humalog-insulin-lispro-in-people-with-diabetes
#7
Philip Home, Karl-Michael Derwahl, Monika Ziemen, Karin Wernicke-Panten, Suzanne Pierre, Yvonne Kirchhein, Satish K Garg
BACKGROUND: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (Humalog® ; Ly-Lis). Two randomized, controlled, open-label, parallel-group, phase 3 studies were conducted to compare the efficacy and safety of SAR-Lis and Ly-Lis, both in combination with insulin glargine (Lantus® ). SORELLA 1 was a 12-month study in 507 people with type 1 diabetes mellitus (T1DM); SORELLA 2 was a 6-month study in 505 people with type 2 diabetes mellitus (T2DM). In this study, the impact of anti-insulin antibodies (AIA) to SAR-Lis and Ly-Lis on safety and glycemic control is reported...
February 2018: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/29232162/efficacy-and-safety-of-biosimilar-sar342434-insulin-lispro-in-adults-with-type-2-diabetes-also-using-insulin-glargine-sorella-2-study
#8
Karl-Michael Derwahl, Timothy S Bailey, Karin Wernicke-Panten, Lin Ping, Suzanne Pierre
BACKGROUND: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (U100; Humalog® ; Ly-Lis). This study aimed to show similar efficacy, safety, and immunogenicity of SAR-Lis versus Ly-Lis in adult patients with type 2 diabetes mellitus (T2DM) treated with multiple daily injections, while using insulin glargine (GLA-100; Lantus® ) as basal insulin. METHODS: SORELLA 2 was a 6-month, randomized, open-label, Phase 3 study (NCT02294474). Insulin doses were adjusted to achieve fasting and 2-h postprandial glucose targets according to American Diabetes Association guidelines...
January 2018: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/29216806/an-industry-update-the-latest-developments-in-therapeutic-delivery
#9
Iain Simpson
This industry update covers the period from 1 September through 30 September 2017, and is based on information sourced from company press releases, scientific literature, patents and various news websites. The month saw the US FDA approve three new molecular entities, Aliqopa (copanlisib dihydrochloride) (Bayer Healthcare); Solosec (secnidazole) (Symbiomix Therapeutics) and Verzenio (abemaciclib) (Eli Lilly and Co). Intarcia Therapeutics Inc. has its application for approval of a novel drug device combination of exenatide for the treatment of diabetes rejected by FDA but said that it will work to address the concerns and refile the application...
January 2018: Therapeutic Delivery
https://www.readbyqxmd.com/read/28846865/insulin-glargine-and-its-two-active-metabolites-a-sensitive-16pm-and-robust-simultaneous-hybrid-assay-coupling-immunoaffinity-purification-with-lc-ms-ms-to-support-biosimilar-clinical-studies
#10
Yang Xu, Li Sun, Melanie Anderson, Philippe Bélanger, Vincent Trinh, Patricia Lavallée, Bhavna Kantesaria, Marie-Josée Marcoux, Sheila Breidinger, Kevin P Bateman, Dina Goykhman, Eric J Woolf
MK-1293 is a newly approved follow-on/biosimilar insulin glargine for the treatment of Type 1 and Type 2 diabetics. To support pivotal clinical studies during biosimilar evaluation, a sensitive, specific and robust liquid chromatography and tandem mass spectrometry (LC-MS/MS) assay for the simultaneous quantification of glargine and its two active metabolites, M1 and M2 were developed. Strategies to overcome analytical challenges, so as to optimize assay sensitivity and improve ruggedness, were evolved, resulting in a fully validated LC-MS/MS method with a lower limit of quantification (LLOQ) at 0...
September 15, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28722480/efficacy-and-safety-of-biosimilar-sar342434-insulin-lispro-in-adults-with-type-1-diabetes-also-using-insulin-glargine-sorella-1-study
#11
Satish K Garg, Karin Wernicke-Panten, Maria Rojeski, Suzanne Pierre, Yvonne Kirchhein, Krystyna Jedynasty
BACKGROUND: SAR342434 is a biosimilar follow-on of insulin lispro-Humalog® . This study aimed to show similar efficacy, safety, and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin glargine (Lantus® ; GLA-100). MATERIALS AND METHODS: SORELLA-1 was a randomized, open-label phase 3 study (NCT02273180). Patients completing the 6-month main study continued on SAR-Lis or Ly-Lis, as randomized, for a 6-month safety extension...
September 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28608570/introduction-of-biosimilar-insulins-in-europe
#12
REVIEW
M Davies, D Dahl, T Heise, J Kiljanski, C Mathieu
Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar(®) ), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize that insulin products are biologicals manufactured through complex biotechnology processes, and thus biosimilar insulins cannot be considered identical to their reference products. Strict regulatory guidelines adopted by authorities in Europe, the USA and some other countries help to ensure that efficacy and safety profiles of biosimilar insulins are not meaningfully different from those of the reference products, preventing entry of biological compounds not meeting quality standards and potentially affecting people's glycaemic outcomes...
October 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28588966/challenges-constraining-access-to-insulin-in-the-private-sector-market-of-delhi-india
#13
Abhishek Sharma, Warren A Kaplan
OBJECTIVE: India's majority of patients-including those living with diabetes-seek healthcare in the private sector through out-of-pocket (OOP) payments. We studied access to insulin in the private-sector market of Delhi state, India. METHODS: A modified World Health Organization/Health Action International (WHO/HAI) standard survey to assess insulin availability and prices, and qualitative interviews with insulin retailers (pharmacists) and wholesalers to understand insulin market dynamics...
November 2016: BMJ Global Health
https://www.readbyqxmd.com/read/28458515/united-states-experience-of-insulin-degludec-alone-or-in-combination-for-type-1-and-type-2-diabetes
#14
REVIEW
Marc Rendell
Insulin degludec has been the product of a sophisticated and systematic biochemical engineering program which began with the release of insulin detemir. The goal was to produce a long-lasting basal insulin with low individual variability. Certainly, this goal has been achieved. Degludec has a duration of action approaching twice that of glargine. Another advantage of degludec is in its lack of unpredictable copolymerization of added aspart. In several studies, degludec has shown lower rates of nocturnal hypoglycemia than glargine...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28371461/comparison-of-morning-basal-1-bolus-insulin-therapy-insulin-glulisine-insulin-glargine-300-u-ml-vs-insulin-lispro-insulin-glargine-biosimilar-using-continuous-glucose-monitoring-a-randomized-crossover-study
#15
Soichi Takeishi, Hiroki Tsuboi, Shodo Takekoshi
INTRODUCTION: We compared the effects of morning administration of insulin glulisine + insulin glargine 300 U/mL (G + G300) with that of insulin lispro + insulin glargine biosimilar (L + GB). MATERIALS AND METHODS: A total of 30 patients with type 2 diabetes who wore a continuous glucose monitoring device on admission after glucose levels were stabilized by morning long-acting and ultra-rapid-acting insulins were randomly allocated to groups who received G + G300 on days 1 and 2, and the same dose L + GB on days 3 and 4, or vice versa...
January 2018: Journal of Diabetes Investigation
https://www.readbyqxmd.com/read/28334539/-long-acting-insulins-in-the-treatment-of-type-2%C3%A2-diabetes-and-their-position-in-the-current-treatment-algorithm
#16
REVIEW
Martin Haluzík
Insulin therapy has been for many years an inseparable part of the treatment of patients with type 2 diabetes, in particular those with longer diabetes duration. Current national and international guidelines list insulin treatment as a possible second choice therapy in patient with unsatisfactory glucose control on monotherapy with metformin. In reality, insulin therapy is often initiated later than it optimally should be. The reasons include among others the fear of patients and sometimes also of physicians from the side effects of insulin...
December 0: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/28210866/cost-effectiveness-of-insulin-degludec-versus-insulin-glargine-in-adults-with-type-1-and-type-2-diabetes-mellitus
#17
Marc Evans, Barrie Chubb, Jens Gundgaard
INTRODUCTION: To estimate the cost-effectiveness of insulin degludec (IDeg) versus insulin glargine U100 (IGlar U100) and new-to-market basal insulin analogues in patients with diabetes in order to aid decision-making in a complex basal insulin market. METHODS: A simple, short-term model was used to evaluate the costs and effects of treatment with IDeg versus IGlar U100 over a 12-month period in patients with type 1 (T1DM) and type 2 diabetes (T2DM) from the perspective of the UK National Health Service...
April 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28118050/administration-of-biosimilar-insulin-analogs-role-of-devices
#18
REVIEW
Lutz Heinemann, Ingo Fritz, Hootan Khatami, Steven V Edelman
With the expiration of patent protection for several originator insulin analog molecules, the availability of insulin analog copies is set to increase. Many regulatory authorities have developed, and continue to refine, guidelines for the approval of biosimilar insulin analogs. Aspects such as the structure, pharmacokinetics and pharmacodynamics, efficacy, safety, and immunogenicity of biosimilar insulin analogs are extensively addressed in these guidelines, but how the biosimilar insulin analog is administered to people with diabetes is not usually a topic...
February 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/27574370/the-future-of-biosimilar-insulins
#19
Anne Park Kim, Ross Jason Bindler
IN BRIEF Biosimilar insulins are available in many countries and will be made available in the United States in the near future. Some concerns associated with biosimilar insulins include potential differences in the efficacy and safety between a biosimilar product and its reference insulin, the ramifications of having the same name or different names for a biosimilar and its reference insulin, the prospects of and limitations to substituting insulin products, and the proper implementation of pharmacovigilance...
August 2016: Diabetes Spectrum: a Publication of the American Diabetes Association
https://www.readbyqxmd.com/read/27565486/-comparison-of-two-insulin-glargine-formulations-biosimilar-vs-reference-product
#20
Elisabeth Mönnig, Nanette Schloot, Cloth Hohberg, Tobias Wiesner, Lutz Heinemann
BACKGROUND: Biosimilar medicinal products have been in use in the European Union since 2006. In September 2014, insulin glargine (LY IGlar) was approved as a long-acting insulin analogue. In accordance with EMA (European Medicines Agency) and FDA (Food and Drug Administration) guidelines, analytical, preclinical and clinical studies were submitted demonstrating drug safety and biosimilarity of LY IGlar with the reference insulin glargine (IGlar). METHOD: In a review article, study data collected in the clinical development of LY IGlar are summarized...
August 2016: MMW Fortschritte der Medizin
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