Basalin (insulin glargine biosimilar) / Gan & Lee Pharma, LG Chem, Sandoz - LARVOL DELTA

Chinese insulin approved in Pakistan (The News International) - "Islamabad: The insulin glargine cartridge by Gan & Lee Pharmaceuticals just obtained the first biosimilar approval from the Drug Regulatory Authority of Pakistan (DRAP). This expected to increase the accessibility of glucose-lowering medications in the local market, China Economic Net (CEN) reported on Wednesday. Data shows that Pakistan has 34.5 million diabetic patients aged 20-79, with a prevalence rate of 31.4%, ranking first in the world."

Approval • Type 2 Diabetes Mellitus

Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Glargine (Gan & Lee Glargine) Compared with Originator Insulin Glargine (Lantus®) in Patients with Type 1 Diabetes after 26 Weeks Treatment. (PubMed, Endocr Pract) - "GL Glargine demonstrated similar immunogenicity, efficacy, and safety compared to Lantus® over 26 weeks in patients with T1DM."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study. (PubMed, Diabetes Obes Metab) - "GL Glargine was similar to Lantus® in terms of immunogenicity, efficacy, and safety, based on the current study."

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

Efficacy, safety and immunogenicity of proposed biosimilar Gan & Lee insulin glargine versus EU-licensed insulin glargine in patients with type 2 diabetes (EASD 2023) - P3 | "This study demonstrated that GL glargine injection is bioequivalent to EU-licensed insulin glargine regarding efficacy, safety, and immunogenicity in patients with T2DM."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy, safety, and immunogenicity of proposed biosimilar Gan & Lee insulin glargine versus EU-licensed insulin glargine in patients with type 1 diabetes (EASD 2023) - P3 | "Supported By Gan & Lee Pharmaceuticals Clinical Trial Registration Number NCT03371082 Background and aims: To assess the bioequivalence (BE) of efficacy, safety, and immunogenicity profiles of GL Glargine Injection, a proposed biosimilar of insulin glargine, with EU-licensed insulin glargine (EU Lantus) in patients with type 1 diabetes mellitus (T1DM)... This study provides evidence of efficacy, safety, and immunogenicity BE of GL Glargine Injection to EU-licensed insulin glargine formulations in patients with T1DM."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Evaluating Glycemic Control During Basalin or Lantus Administration in Adults With Controlled Type 2 Diabetes Mellitus Using Continuous Glucose Monitoring. (PubMed, Front Endocrinol (Lausanne)) - "In patients with well-controlled T2DM who were treated with insulin glargine, Lantus group showed lower MBG, GV, and lower PT (BG > 10.0 mmol/L, BG > 13.9 mmol/L) than Basalin group. In summary, for T2DM population with HbA1c ≤ 7%, Lantus may be a better choice compared with Basalin."

Clinical • Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

[VIRTUAL] Proposed Biosimilar Gan & Lee Insulin Glargine (GL-GLA) Shows Pharmacokinetic (PK) and Pharmacodynamic (PD) Bioequivalence (BE) to U.S.- and EU-Licensed Insulin Glargine (IG) (ADA 2021) - P1 | "This randomized, double-blind, three-way crossover trial (NCT04236895) compared the PK and PD properties of GL-GLA, a proposed biosimilar IG by Gan & Lee, US- and EU-licensed Lantus ® (US-IG and EU-IG) in 114 male subjects with type 1 diabetes (mean±SD age 42±8 years, BMI 25.8±2.0 kg/m²)...All insulins were well tolerated with similar adverse event rates (19% [GL-GLA]; 26% [US-IG]; 21% [EU-IG]) and only few events of injection site reactions per insulin. In conclusion, GL-GLA demonstrated both PK- and PD-bioequivalence to US- and EU-licensed insulin glargine formulations."

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

GLITTER 2: Gan & Lee Insulin Glargine Target Type (2) Evaluating Research (clinicaltrials.gov) - P3; N=550; Completed; Sponsor: Gan and Lee Pharmaceuticals, USA; Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

GLITTER 1: Gan & Lee Insulin Glargine Target Type (1) Evaluating Research (clinicaltrials.gov) - P3; N=550; Completed; Sponsor: Gan and Lee Pharmaceuticals, USA; Active, not recruiting ➔ Completed; Trial completion date: Feb 2020 ➔ Aug 2019; Trial primary completion date: Feb 2020 ➔ Aug 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus: a retrospective chart review. (PubMed, F1000Res) - " In this study population, switching from Basalin to Lantus was associated with further reductions in blood glucose, although the dose of insulin glargine did not increase. Further studies are required to verify these findings and determine the reason for this phenomenon."

Journal • Retrospective data • Biosimilar • Diabetes • Severe Hypoglycemia

A Propensity Score Matched Comparison of Brand and Biosimilar Basal Insulin in Non-Critical Hospitalized Patients with Type 2 Diabetes Mellitus. (PubMed, Adv Ther) - "In a non-critical hospital setting, subcutaneous treatment with Lantus brought significant FBG improvement without increased hypoglycemic risk."

Clinical • Journal • Retrospective data

Basalin is an evolutionarily unconstrained protein revealed via a conserved role in flagellum basal plate function. (PubMed, Elife) - "Basalins are predicted to be highly unstructured, suggesting they may act as 'hubs' facilitating many protein-protein interactions. This raises the general concept that proteins involved in cytoskeletal functions and appearing organism-specific, may have highly divergent and cryptic orthologs in other species."

Journal

GLITTER 2: Gan & Lee Insulin Glargine Target Type (2) Evaluating Research (clinicaltrials.gov) - P3; N=550; Active, not recruiting; Sponsor: Gan and Lee Pharmaceuticals, USA; Recruiting ➔ Active, not recruiting; Trial primary completion date: Oct 2019 ➔ Feb 2020

Clinical • Enrollment closed • Trial primary completion date

GLITTER 1: Gan & Lee Insulin Glargine Target Type (1) Evaluating Research (clinicaltrials.gov) - P3; N=550; Active, not recruiting; Sponsor: Gan and Lee Pharmaceuticals, USA; Recruiting ➔ Active, not recruiting; Trial primary completion date: Oct 2019 ➔ Feb 2020

Clinical • Enrollment closed • Trial primary completion date

PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients (clinicaltrials.gov) - P1; N=114; Completed; Sponsor: Gan and Lee Pharmaceuticals, USA

Clinical • New P1 trial

Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P4; N=100; Recruiting; Sponsor: Nanjing First Hospital, Nanjing Medical University; Not yet recruiting ➔ Recruiting; Trial completion date: Jan 2019 ➔ Jul 2019

Clinical • Enrollment open • Trial completion date