New Insulins, Biosimilars, and Insulin Therapy

Possible Ways to Improve Postprandial Glucose Control in Type 1 Diabetes

“…Due to the rising cost of insulin, biosimilar insulins are also now being developed as an alternative to the established branded RAIA. [93][94][95] Similar PK/PD results have been demonstrated with biosimilar lispro versus insulin lispro in use. 96 A crossover study that compared biosimilar lispro and insulin lispro in use for pump compatibility and safety found similar results for infusion set occlusions, hypersensitivity reactions, and hypoglycemia events.…”

“…It had previously demonstrated an accelerated insulin action profile across multiple phase 1 and 2 studies in people with T1D and T2D compared to insulin lispro. [102][103][104] A trial (NCT03179332) that compared PK/PD properties of BioChaperone insulin lispro in insulin pumps with insulin aspart and FIasp recently showed superior results according to a press release by Adocia, Inc. (Lyon, France). 105 Eli Lilly & Co, Inc. (Indianapolis, IN) recently completed the recruitment for the phases 2 to 3 trials for ultra-rapid-acting insulin lispro for MDI and continuous subcutaneous insulin infusion (CSII) (NCT03056456 and NCT02703350).…”

“…105 Eli Lilly & Co, Inc. (Indianapolis, IN) recently completed the recruitment for the phases 2 to 3 trials for ultra-rapid-acting insulin lispro for MDI and continuous subcutaneous insulin infusion (CSII) (NCT03056456 and NCT02703350). 104 Results from early phase studies of this compound supported faster time action profile than insulin lispro, although full results of phase 3 studies are not currently available. 106,107 Some other alternative methods have been tried to increase insulin absorption.…”

Safety signals assessed by the pharmacovigilance risk assessement committee: biologics vs conventional medicines

“…Biologics are macromolecules larger in size than synthetic small molecule drugs, require more resources for production, and have a higher cost. The development of biologics led to the treatment improvement of several serious and chronic diseases such as cancer, autoimmune conditions, diabetes, and anemia (18)(19)(20)(21). Knowledge about the safety profile of new drugs is not complete at the time of approval (Marketing Authorization -MA), primarily due to intrinsic limitations of clinical trials, among other reasons.…”

“…Os medicamentos biológicos são macromoléculas de dimensões superiores às das pequenas moléculas sintéticas, exigem mais recursos na produção e são mais caros. O desenvolvimento de medicamentos biológicos melhorou o tratamento de muitas doenças graves e crónicas, como o cancro, doenças autoimunes, diabetes e anemia (18)(19)(20)(21). O conhecimento sobre o perfil de segurança de novos medicamentos não está completo aquando do momento da aprovação (Autorização de introdução no mercado -AIM), devido às limitações intrínsecas dos ensaios clínicos, entre outras razões.…”