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

Q2 · MEDICINE

Article

Author: Sharma, Nirant ; Loganathan, Subramanian ; Plum‐Mörschel, Leona ; Singh, Gursharan ; Klein, Oliver ; Lakshmi, Gopu Chandrasekharan ; Panda, Jayanti ; Marwah, Ashwani ; Murugesan, Sundara Moorthi Nainar ; Athalye, Sandeep N.

AbstractAimTo 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 MethodsIn 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.ResultsEquivalence 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.ConclusionPK/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.

100 Deals associated with Recombinant human insulin(Tonghua Dongbao Pharmaceutical Co., Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10AF01 A10AD01 A10AC01 A10AB01 A10AE01	DB00030

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus	CN	Tonghua Dongbao Pharmaceutical Co., Ltd.	01 Jan 1998

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	NDA/BLA	EU	Tonghua Dongbao Pharmaceutical Co., Ltd.	01 Feb 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

Recombinant human insulin(Tonghua Dongbao Pharmaceutical Co., Ltd.)

Overview

Basic Info

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation