Prandilin (insulin lispro biosimilar) / Gan & Lee Pharma, Sandoz - LARVOL DELTA

Patients with type 2 diabetes who achieve reduced postprandial glucose levels during insulin intensive therapy may have a better recovery of β-cell function. (PubMed, Diabetes Res Clin Pract) - "Drug-naïve T2D patients with lower postprandial glucose concentration during CSII therapy exhibit better β-cell function recovery."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU- und US-sourced reference insulins. (PubMed, Diabetes Obes Metab) - "GL-Asp, GL-Lis and GL-Gla are bioequivalent to their EU- and US-reference products."

Clinical • Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

"Yesterday, @GanLee_ announced @US_FDA had accepted its application for biosimilar insulin lispro, today it announced the same for insulin aspart. https://t.co/AzRFSQYinL" (@sstrumello)

[VIRTUAL] Proposed biosimilar insulin lispro (GL-LIS) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence versus US-licenced and EU-authorised insulin lispro (EASD 2021) - P1 | "GL-LIS demonstrated both PK and PD bioequivalence and similar safety profile to US-LIS and EU-LIS formulations."

PK/PD data • Metabolic Disorders

GENTL 1: Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Gan and Lee Pharmaceuticals, USA

Clinical • New P3 trial

PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Gan and Lee Pharmaceuticals, USA

Clinical • New P1 trial

Efficacy Comparison of Preprandial and Postprandial Prandilin 25 Administration in Patients with Newly Diagnosed Type 2 Diabetes Using a Continuous Glucose Monitoring System. (PubMed, Diabetes Ther) - "In patients with T2DM managed with premixed insulin lispro 25, postprandial injection (within 30 min of meal onset) may be an acceptable alternative to preprandial injection when the regular preprandial insulin dose is omitted."

Clinical • Journal