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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/29466056/a-guide-to-follow-on-biologics-and-biosimilars-with-a-focus-on-insulin
#5
Richard Dolinar, Frank Lavernia, Steven Edelman
OBJECTIVE: Many healthcare providers in the U.S. are not familiar with follow-on biologics and biosimilars nor with their critical distinctions from standard generics. Our aim is to provide a detailed review of both, with a focus on insulins in the U.S. regulatory system. METHODS: Literature has been reviewed to provide information on various aspects of biosimilars and a follow-on biologic of insulin. This will include structure, efficacy, cost, switching, and legal issues...
February 2018: Endocrine Practice
https://www.readbyqxmd.com/read/29437477/new-insulins-biosimilars-and-insulin-therapy
#6
Thomas Danne, Lutz Heinemann, Jan Bolinder
No abstract text is available yet for this article.
February 2018: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/29368288/ly2963016-insulin-glargine-a-review-in-type-1-and-2-diabetes
#7
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
#8
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
#9
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
#10
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/29109610/how-similar-are-biosimilars-what-do-clinicians-need-to-know-about-biosimilar-and-follow-on-insulins
#11
Curtis Triplitt, Debbie Hinnen, Virginia Valentine
IN BRIEF As more patents on biological medicines expire, increased numbers of biologic copies, referred to as "biosimilars," will likely become available in the United States in the coming years. With greater availability and the drive for health care savings, the use of biosimilars and of "follow-on" biological products is likely to increase in routine clinical practice. Health care practitioners need to be fully aware of these products and accompanying considerations if they are to make informed decisions together with their patients...
October 2017: Clinical Diabetes: a Publication of the American Diabetes Association
https://www.readbyqxmd.com/read/28885037/will-biosimilar-insulins-be-cheaper
#12
Lutz Heinemann, Alan W Carter
No abstract text is available yet for this article.
September 2017: Diabetes Technology & Therapeutics
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
#13
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
#14
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/28642701/the-market-of-biopharmaceutical-medicines-a-snapshot-of-a-diverse-industrial-landscape
#15
Evelien Moorkens, Nicolas Meuwissen, Isabelle Huys, Paul Declerck, Arnold G Vulto, Steven Simoens
Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market. Objectives: This study aims to identify and document which investment and development strategies are adopted by industrial players in the global biopharmaceutical market. Methods: A descriptive analysis was undertaken of the investment and development strategies of the top 25 pharmaceutical companies according to 2015 worldwide prescription drug sales...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28637743/knowledge-attitude-and-practice-of-healthcare-professionals-towards-infliximab-and-insulin-glargine-biosimilars-result-of-a-uk-web-based-survey
#16
Stephen R Chapman, Raymond W Fitzpatrick, Mohammed I Aladul
OBJECTIVE: To investigate healthcare professionals' knowledge and attitudes towards infliximab and insulin glargine biosimilars and the factors influencing their prescribing. Then, to compare healthcare professionals' attitudes with the utilisation of these biosimilars in UK hospitals. DESIGN: Self-administered, one-time web-based survey and drug utilisation analysis. SETTING AND DATA SOURCES: Professional associations and societies in the field of dermatology, diabetology, gastroenterology and rheumatology in the UK, between 8 August 2016 and 8 January 2017...
June 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28608570/introduction-of-biosimilar-insulins-in-europe
#17
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
#18
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/28526658/nonclinical-pharmacology-and-toxicology-of-the-first-biosimilar-insulin-glargine-drug-product-basaglar-%C3%A2-abasaglar-%C3%A2-approved-in-the-european-union
#19
Richard A Byrd, Rebecca A Owens, Jamie L Blackbourne, David E Coutant, Mark W Farmen, M Dodson Michael, Julie S Moyers, A Eric Schultze, Michael K Sievert, Niraj K Tripathi, John L Vahle
Basaglar(®)/Abasaglar(®) (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus(®) (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We assessed the similarity of LY IGlar to the reference drug product, European Union-sourced SA IGlar (EU-SA IGlar), using nonclinical in vitro and in vivo studies. No biologically relevant differences were observed for receptor binding affinity at either the insulin or insulin-like growth factor-1 (IGF-1) receptors, or in assays of functional or de novo lipogenic activity...
May 17, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28458515/united-states-experience-of-insulin-degludec-alone-or-in-combination-for-type-1-and-type-2-diabetes
#20
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
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