Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar <scp>Insulin‐R</scp> with the <scp>US</scp>‐licensed <scp>Humulin® R</scp> formulation in healthy subjects: Results from the <scp>RHINE</scp>‐1 (<scp>Recombinant Human INsulin Equivalence‐1</scp>) study

el, None Leona Plum‐Mörsch; Singh, Gursharan; Murugesan, Sundara Moorthi Nainar; Marwah, Ashwani; Panda, J. N.; Loganathan, Subramanian; Athalye, Sandeep N.

doi:10.1111/dom.14635

Cited by 8 publications

(2 citation statements)

References 23 publications

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“…This drug was initially discovered and developed by Amgen Inc and is marketed under the brand names like epoetin-α hexal, epogen, abseamed, epprex. It is in the usage for treating anemia associated complications such as antiviral drug therapy, chronic renal failure, and high-risk perioperative blood loss post-surgical procedures by increasing differentiation from progenitor cells to red blood cells [73]. Epotein-α was approved by the FDA in the year 1981.…”

Section: Erythropoietinmentioning

confidence: 99%

An Investigation into the World of Protein-Based Therapeutics-Therapeutic Proteins

A¹

2023

J Clin Med Res.

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Protein based therapeutics have been regarded very highly as they have produced immense results in treating various diseases including genetic disorders, neurodegenerative disorders, sexually transmitted diseases, and autoimmune disorders. This has revolutionized the field of medicine by enabling precise targeting for treating diseases and personalized medicine for different individuals. The ability to target the source of a disease or disorder has made this line of therapeutics a major outbreak for revolutionizing the field of targeted medicine and is currently being pursued for developing novel therapeutics. The production of recombinant protein paved the way for these therapeutics and despite the considerable progress made so far in the study and production of therapeutic proteins, there are still concerns over its off-target effects and ethical considerations, which have spurred the exploration of alternative approaches. In this context, this article is presented on therapeutic proteins, an innovative biological approach that has the potential to cure disorders that were once considered incurable. This article highlights the limitations of current targeted medicine technologies and the need for more targeted and personalized approaches to treat genetic disorders. Employing artificially synthesized therapeutic proteins such as monoclonal antibodies (MAC) to target specific cells, tissues, organs, genes, proteins, and sites of disease progression has proven to be more effective in treating the diseases. This approach provides greater specificity and control over various disorders, making it a highly promising therapeutic option for various diseases such as cancer, cardiovascular diseases, and viral infections. This article discusses the status of therapeutic proteins, their potential prospects, as well as the challenges and opportunities that need to be addressed to fully exploit their potential. Overall, the article aims to shed light on the significance of therapeutic medicine in the field of medicine and its potential to revolutionize treatments for various disorders. By providing an overview of this innovative approach, it hopes to inspire further research in this area and pave the way for novel and more effective therapies for genetic disorders.

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Section: Erythropoietinmentioning

confidence: 99%

An Investigation into the World of Protein-Based Therapeutics-Therapeutic Proteins

A¹

2023

J Clin Med Res.

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“…This article is the second in a series of clinical study publications aimed at evaluating the PK/PD equivalence of Biocon's rHIs versus reference biologics in healthy subjects (RHINE studies). Results from RHINE‐1 have been published earlier 19 . This study assesses the PK/PD equivalence and the safety and tolerability of Biocon's Insulin‐70/30 and HUMULIN‐70/30 using the euglycaemic clamp technique in healthy subjects.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US‐licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE‐3 (Recombinant Human INsulinEquivalence‐3) study

Plum‐Mörschel

Klein

Singh

et al. 2022

Diabetes Obesity Metabolism

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Aim To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon's Insulin‐70/30) and HUMULIN® 70/30 (HUMULIN‐70/30; Eli Lilly and Company, IN). Materials and Methods In this phase 1, automated euglycaemic glucose clamp study, 78 healthy subjects were randomized (1:1) to receive a single dose of 0.4 IU/kg of Biocon's Insulin‐70/30 and HUMULIN‐70/30. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24 hours. Primary PK endpoints were area under the insulin concentration‐time curve from 0 to 24 hours ‐ AUCins.0−24h ‐ and maximum insulin concentration ‐ Cins.max. Primary PD endpoints were area under the GIR time curve from 0 to 24 hours ‐ AUCGIR.0−24h ‐ and maximum GIR ‐ GIRmax. Results Equivalence was shown between Biocon's Insulin‐70/30 and HUMULIN‐70/30 for the primary PK/PD endpoints. The 90% confidence intervals of the treatment ratios were entirely within the acceptance range of 80.00%‐125.00%. The secondary PK/PD profiles were also comparable. There were no clinically relevant differences in the safety profiles of the two treatments and no serious adverse events were reported. Conclusion PK/PD equivalence was demonstrated between Biocon's Insulin‐70/30 and HUMULIN‐70/30 in healthy subjects. Treatment with Biocon's Insulin‐70/30 and HUMULIN‐70/30 was well tolerated.

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Effects of Unsuppressed Endogenous Insulin on Pharmacokinetics and/or Pharmacodynamics of Study Insulin in the Healthy: A Retrospective Study

Liu

Sun

et al. 2022

Clinical Pharm in Drug Dev

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C‐peptide, a marker of endogenous insulin, should be consistently inhibited during euglycemic clamping, while an elevated postdosing C‐peptide (CPpostdosing) is not an occasional phenomenon. This was a retrospective study that included 33 men who underwent a manual euglycemic clamp with a subcutaneous injection of insulin aspart (IAsp) aiming to describe the effects of insufficient suppression of endogenous insulin on estimates of the pharmacokinetics and pharmacodynamics of injected insulin. The time profiles of whole blood glucose, human insulin, glucose infusion rate (GIR), and C‐peptide were recorded. The subjects were divided into 2 groups at a ratio of 2:1: group A ([CPpostdosing]max>baseline CP [CPbaseline]), group B ([CPpostdosing]max ≤ CPbaseline). The endogenous insulin was approximately equal to the measured value of human insulin or calculated from the C‐peptide. The basal glucose, CPbaseline, basal human insulin, homeostatic model assessment of insulin resistance, IAsp dose, and demographic statistics were all comparable between the 2 groups except the “clamped” glucose. The average clamped glucose was 99.7% (group A) and 94.9% (group B) of baseline. After correction for clamped glucose, GIR area under the concentration‐time curve from time 0 to 8 hours was higher in group A (P < .05) under comparable IAsp exposure. Endogenous insulin area under the concentration‐time curve from time 0 to 8 hours calculated from C‐peptide was different from that measured from human insulin in group A (P < .05), whereas no statistical difference between these measures was observed in group B. Hence, blood glucose should be controlled below the baseline to ensure the inhibition of endogenous insulin. Unsuppressed endogenous insulin may contribute to observed GIR, and the endogenous insulin–corrected pharmacokinetics estimated by C‐peptide may be inaccurate with insufficient endogenous insulin suppression.

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Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin‐R with the US‐licensed Humulin® R formulation in healthy subjects: Results from the RHINE‐1 (Recombinant Human INsulin Equivalence‐1) study

Cited by 8 publications

References 23 publications

An Investigation into the World of Protein-Based Therapeutics-Therapeutic Proteins

An Investigation into the World of Protein-Based Therapeutics-Therapeutic Proteins

Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US‐licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE‐3 (Recombinant Human INsulinEquivalence‐3) study

Effects of Unsuppressed Endogenous Insulin on Pharmacokinetics and/or Pharmacodynamics of Study Insulin in the Healthy: A Retrospective Study

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