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biosimilar diabetes

Tomohide Yamada, Ryuichi Kamata, Kotomi Ishinohachi, Nobuhiro Shojima, Sophia Ananiadou, Hisashi Noma, Toshimasa Yamauchi, Takashi Kadowaki
Biosimilar insulins have expanded treatment options for diabetes. We compared clinical efficacy and safety between biosimilar and originator insulins by meta-analysis. Random effects meta-analysis was performed on randomized controlled trials comparing biosimilar and originator insulins in adults with diabetes from electronic databases up to December 2017. Ten trials (4,935 patients) were assessed (2 each for LY2963016, MK-1293, Mylan's insulin glargine, and SAR342434, and 1 each for FFP-112 and Basalog). Meta-analysis revealed no differences between long-acting biosimilar and originator insulins for reduction of hemoglobin A1c at 24 weeks (0...
March 14, 2018: Diabetes, Obesity & Metabolism
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
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
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
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
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
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
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
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
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
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
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...
March 28, 2017: Journal of Diabetes Investigation
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
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
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
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
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
Walter Alexander
We present EULAR sessions on the latest treatments for rheumatic disease with an infliximab biosimilar, certolizumab pegol, secukinumab, and bimekizumab. We also report on significant developments in diabetes presented at ADA's Scientific Sessions.
August 2016: P & T: a Peer-reviewed Journal for Formulary Management
Alan W Carter, Lutz Heinemann
Insulin prices in the United States have risen dramatically in recent years, yet pharmacies cannot provide a stable price for a given insulin due to factors that are not widely understood. This commentary discusses the complex and obscure factors that drive today's insulin prices with a discussion of the other players, besides the insulin manufacturer, who benefit from higher prices. An open discussion is critical regarding this drug and others that are essential to the lives of millions of people with diabetes...
November 2016: Journal of Diabetes Science and Technology
Colby Evans
The chronic and systemic nature of psoriasis has a significant impact on direct costs, indirect costs, and patient quality of life. Psoriasis is associated with comorbid conditions that add to the burden of the disease, especially in moderate to severe disease. The total estimated annual healthcare burden of psoriasis may be as high as $35.2 billion, with $12.2 billion in direct costs and $23 billion in indirect costs (attributed to reduced health-related quality of life and lost productivity). These costs vary based on the severity of the disease; pharmacy costs account for the majority of the burden, especially in severe disease...
June 2016: American Journal of Managed Care
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