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JOURNAL ARTICLE
Robin Feldman
No abstract text is available yet for this article.
August 7, 2023: JAMA Internal Medicine
#22
JOURNAL ARTICLE
Ashish Rai, Young Hee Nam, Aaron B Mendelsohn, James Marshall, Cara L McDermott, Sengwee Toh, Catherine M Lockhart
BACKGROUND: The first follow-on drug (Basaglar) of the originator insulin glargine (Lantus), a long-acting insulin for treatment of type 1 and type 2 diabetes mellitus (T1DM, T2DM), was approved in 2015 in the United States. Information on the uptake, user characteristics, and outcomes of follow-on insulin remains sparse. OBJECTIVE: To describe the utilization, user characteristics, and health outcomes of the follow-on insulin glargine and insulin glargine originators in a large, distributed network of primarily commercially insured patients in the United States...
July 2023: Journal of Managed Care & Specialty Pharmacy
#23
JOURNAL ARTICLE
Akshay G Mishra, Rutuja B Deshmane, Damodar K Thappa, Jeseena Lona, Nikhil S Ghade, Sanjay M Sonar, Archana R Krishnan
BACKGROUND: Bioassays are used to identify the pharmacological activity of new or chemically unknown compounds, as well as their undesirable effect, including toxicity. Biological assays are also required to ensure the quality, safety, and efficacy of recombinant biologics to confirm its biosimilarity to its originator. In the present study, analytical similarity between the biosimilar and its innovator is established by in vitro bioassays. OBJECTIVE: The objective of this study was to show the comparative in vitro characterization of the recombinant insulin aspart from BioGenomics with its originator insulin aspart, using relevant biological assays...
June 7, 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
#24
JOURNAL ARTICLE
Philip Home
Insulin injections have never been an entirely satisfactory therapy, and as a result a continuing 'biobetter' technological cascade has driven changes in purity and manufacture, in structure and excipients, and in administration devices. The resulting deck of insulin preparations has to be matched by health-care teams and users with individual need. This latter is itself a complex ranging from ambulatory care in type 1 and type 2 diabetes, the topic generally addressed by guidelines and funding advice, to in-patient care and the newly diagnosed, plus secondary diabetes with very different effects on insulin need, through to co-morbidities and medications interfering with glucose metabolism...
May 18, 2023: Journal of the Royal College of Physicians of Edinburgh
#25
JOURNAL ARTICLE
Masanori Hasebe, Shinobu Satoh, Kohei Ito, Haruka Tamura, Yasuo Terauchi
We investigated the pathophysiology of the dawn phenomenon by examining the effects of changes in blood glucose levels from late night to early morning on various hormones in a group taking glargine BS and a group taking Lantus XR, with the goal of achieving better glycemic control. Patients with types 1 and 2 diabetes scheduled for inpatient education were divided into BS and XR groups. Blood glucose levels were tracked from 0:00 to 7:00, while blood samples were extracted at 3:00 and 7:00 to measure glucose levels and hormones related to the dawn phenomenon...
May 11, 2023: Endocrine Journal
#26
JOURNAL ARTICLE
Kelly E Anderson, Andrew Xuan, Gerard F Anderson, Mariana P Socal
No abstract text is available yet for this article.
May 8, 2023: JAMA Internal Medicine
#27
REVIEW
Anirban Das, Mosami Shah, Ishu Saraogi
Protein aggregation leading to the formation of amyloid fibrils has various adverse effects on human health ranging from fatigue and numbness to organ failure and death in extreme cases. Insulin, a peptide hormone commonly used to treat diabetes, undergoes aggregation at the site of repeated injections in diabetic patients as well as during its industrial production and transport. The reduced bioavailability of insulin due to aggregation hinders the proper control of glucose levels in diabetic patients. Thus, it is necessary to develop rational approaches for inhibiting insulin aggregation, which in turn requires a detailed understanding of the mechanism of fibrillation...
June 15, 2022: ACS Bio Med Chem Au
#28
JOURNAL ARTICLE
Simon Heller, João Filipe Raposo, Santiago Tofé, Wasim Hanif, Zbynek Schroner, Su Down, Thomas Blevins
Despite increases in the availability and effectiveness of other therapies, insulin remains an essential treatment for approximately 30 million people with type 2 diabetes worldwide. The development of biosimilars has created the potential for significant health care cost savings and may lead to greater access to basal insulin for vast populations. In this review, we discuss evidence demonstrating equipoise between basal insulin biosimilars and the patented analogs they may replace.
2023: Clinical Diabetes: a Publication of the American Diabetes Association
#29
JOURNAL ARTICLE
Huarui Shao, Yi Tao, Chengyong Tang
Objective: This study aimed to explore the factors affecting the bioequivalence of test and reference insulin preparations so as to provide a scientific basis for the consistency evaluation of the quality and efficacy of insulin biosimilars. Methods: A randomized, open, two-sequence, single-dose, crossover design was used in this study. Subjects were randomly divided into TR or RT groups in equal proportion. The glucose infusion rate and blood glucose were measured by a 24-h glucose clamp test to evaluate the pharmacodynamic parameters of the preparation...
2023: Frontiers in Pharmacology
#30
Brian Godman, Magdalene Wladysiuk, Stuart McTaggart, Amanj Kurdi, Eleonora Allocati, Mihajlo Jakovljevic, Francis Kalemeera, Iris Hoxha, Anna Nachtnebel, Robert Sauermann, Manfred Hinteregger, Vanda Marković-Peković, Biljana Tubic, Guenka Petrova, Konstantin Tachkov, Juraj Slabý, Radka Nejezchlebova, Iva Selke Krulichová, Ott Laius, Gisbert Selke, Irene Langner, András Harsanyi, András Inotai, Arianit Jakupi, Svens Henkuzens, Kristina Garuolienė, Jolanta Gulbinovič, Patricia Vella Bonanno, Jakub Rutkowski, Skule Ingeberg, Øyvind Melien, Ileana Mardare, Jurij Fürst, Sean MacBride-Stewart, Carol Holmes, Caridad Pontes, Corinne Zara, Marta Turu Pedrola, Mikael Hoffmann, Vasileios Kourafalos, Alice Pisana, Rita Banzi, Stephen Campbell, Bjorn Wettermark
[This corrects the article DOI: 10.1155/2021/9996193.].
2023: BioMed Research International
#31
JOURNAL ARTICLE
Thomas Danne, Lutz Heinemann, Thomas R Pieber
No abstract text is available yet for this article.
February 2023: Diabetes Technology & Therapeutics
#32
JOURNAL ARTICLE
Grit Andersen, Gursharan Singh, Sundara Moorthi Nainar Murugesan, Rajesh Gogineni, Nirant Sharma, Jayanti Panda, Ashwani Marwah, Subramanian Loganathan, Sandeep N Athalye
AIM: To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin N (Biocon's Insulin-N) and US-licensed Humulin® N (Humulin-N; Eli Lilly and Company, IN) in healthy subjects. MATERIALS AND METHODS: This was a phase-1, single-center, double-blind, randomized, three-period, six-sequence, partially replicated, crossover, 24-h euglycemic clamp study. Overall, 90 healthy subjects were randomized, of whom 85 completed the study...
January 28, 2023: Diabetes, Obesity & Metabolism
#33
JOURNAL ARTICLE
Mandy Mohnicke, Arnd Blecher, Kathrin Beichert, Bernd Bidlingmaier, Ernst-Josef Todt, Christoph Dette, Baerbel Rotthaeuser, Bhaswati Mukherjee
SAR341402 (Insulin aspart Sanofi®) is an insulin aspart biosimilar that can be used for continuous subcutaneous insulin infusion (CSII) in pump systems. The physicochemical stability of SAR341402 for CSII use was evaluated in several in vitro experiments. Insulin aspart products (SAR341402, NovoLog®, NovoRapid®) were filled into pump reservoirs and pumped through Medtronic insulin pumps (MiniMedTM 530G-Model 751, Medtronic, Northridge, CA) and their related infusion sets under simulated stress conditions, including elevated temperature and mechanical agitation on a continuously vibrating platform, up to 13 days...
December 12, 2022: Journal of Pharmaceutical Sciences
#34
JOURNAL ARTICLE
Roman V Drai, Alexander Y Mayorov, Tatiana L Karonova, Tatiana M Parfenova, Igor E Makarenko, Maxim A Magruk, Diana N Alpenidze, Vladislav V Kovalik, Bella R Zinnatulina, Irina V Grigorjeva, Alena T Andreeva
Aim: To evaluate the safety and efficacy of insulin Aspart-Mix biosimilar candidate GP40081 (GP-Asp30) compared with NovoMix® 30 (NN-Asp30). Materials & methods: In a randomized open-label, active-controlled, 26-week non-inferiority clinical trial 264 patients with Type 2 diabetes mellitus were randomized 1:1 to receive once-daily GP-Asp30 or NN-Asp30. The primary safety end point was the immune response rate. Efficacy outcomes were a mean change in HbA1c (primary), frequency of achieving a glycemic g fasting plasma glucose levels, 7-point glucose profiles, and insulin doses...
December 13, 2022: Journal of Comparative Effectiveness Research
#35
JOURNAL ARTICLE
Morgane C Mouslim, Emaan S Rashidi, Joseph F Levy, Mariana P Socal, Antonio J Trujillo
OBJECTIVES: To describe the uptake and out-of-pocket (OOP) costs of Basaglar, the first long-acting insulin biosimilar, in a commercially insured population in the United States. STUDY DESIGN: Retrospective analysis of commercial pharmacy claims and pharmacy co-payment offsets. METHODS: We assessed Basaglar uptake by examining trends in the composition of the long-acting insulin market in the United States from 2014 to 2018. As patient demographics and plan type may be important determinants of biosimilar uptake, we also assessed characteristics of all long-acting insulin users by drug...
November 1, 2022: American Journal of Managed Care
#36
JOURNAL ARTICLE
Louis P Garrison, Boshen Jiao, Omar Dabbous
OBJECTIVES: Conventional cost-effectiveness analysis (CEA) for the value-based pricing of new medicines largely ignores the implications of limited market exclusivity (ie, patent-protection periods plus any exclusivity granted by regulators). This paper explores the implications of this methodological shortcoming, which produces several pricing anomalies with potentially unintended effects on research and development (R&D) incentives. METHODS: We illustrate these implications by comparing 4 stylized examples of increasing complexity, from short-term cures for acute conditions to long-term cures for rare, health-catastrophic conditions...
November 3, 2022: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
#37
JOURNAL ARTICLE
Viswanathan Mohan, Wolfgang Schmider, Kiran P Singh, Baerbel Rotthaeuser, Bhaswati Mukherjee, S R Aravind
Background: We compared the pharmacokinetic exposure, efficacy, safety and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (SARAsp -Mix) with its originator NovoMix® 30 insulin aspart mix (NN-Mix) in adults with type 2 diabetes. Methods: This was a randomized, open-label, parallel-group, substudy of the phase 3 GEMELLI M trial performed in three Indian centres. Totally 13 Indian participants previously treated with premix insulin received a single subcutaneous 0...
July 2022: Indian Journal of Endocrinology and Metabolism
#38
JOURNAL ARTICLE
Thomas C Blevins, Yaron Raiter, Bin Sun, Charles Donnelly, Roxann Shapiro, Anoop Chullikana, Anita Rao, Laxmikant Vashishta, Gopinath Ranganna, Abhijit Barve
BACKGROUND: MYL-1601D is a proposed biosimilar of originator insulin aspart, Novolog® /NovoRapid® (Ref-InsAsp-US/Ref-InsAsp-EU). OBJECTIVE: This study assessed the immunogenicity, efficacy, and safety of MYL-1601D with Ref-InsAsp-US in patients with type 1 diabetes mellitus (T1D). METHODS: This was a 24-week, open-label, randomized, phase III study. Patients were randomized 1:1 to mealtime MYL-1601D or Ref-InsAsp-US in combination with insulin glargine (Lantus SoloSTAR® ) once daily...
September 17, 2022: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
#39
JOURNAL ARTICLE
Yiya Wang, Ying Zhou, Juefang Ding, Xianjing Li, Fengxue Guo, Jianfei Zhang, Li Ding
Insulin glargine is a long-acting insulin analog, which plays an important role in the treatment of diabetes mellitus. Biosimilar products of insulin glargine can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes. This article presents a randomized, double-blind, single-dose, two-treatment, four-period, replicate crossover, euglycemic clamp study which was designed to evaluate the PK and PD similarity between the recombinant insulin glargine developed by Wanbang (test) and Lantus® (reference) in healthy volunteers...
2022: Frontiers in Pharmacology
#40
REVIEW
Jayabharathi Vaidyanathan, Yow-Ming C Wang, Doanh Tran, Shirley K Seo
There is over a hundred years of clinical experience with insulin for the treatment of diabetes. The US Food and Drug Administration (FDA) approved the first insulin biosimilar interchangeable product in 2021 for improving glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Several recombinant insulin products are available in the United States, including the recently approved biosimilar insulins. The approval of the biosimilar insulin products was based on comparative analytical characterizations and comparative pharmacokinetic (PK) and pharmacodynamic (PD) data...
September 2, 2022: Clinical Pharmacology and Therapeutics
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