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- || Basalin (insulin glargine biosimilar) / Gan & Lee Pharma, LG Chem, Sandoz, Prandilin (insulin lispro biosimilar) / Gan & Lee Pharma, Sandoz, Rapilin (Gan & Lee Insulin Aspart biosimilar) / Gan & Lee Pharma, Sandoz
Clinical, PK/PD data, Journal: Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin (Pubmed Central) - Nov 13, 2023
GL-Asp, GL-Lis and GL-Gla are bioequivalent to their EU- and US-reference products.
- GL-ASP (Gan & Lee Insulin Aspart biosimilar) / Gan & Lee Pharma
[VIRTUAL] Phase 3 confirmatory study comparing efficacy and safety of proposed biosimilar and reference insulin aspart, combined with metformin, in patients with diabetes (Rome Hall) - Jul 13, 2021 - Abstract #EASD2021EASD_759;
GL-Asp, GL-Lis and GL-Gla are bioequivalent to their EU- and US-reference products. The efficacy, safety, and immunogenicity of GL-ASP matched that of NN-ASP in patients with type 2 diabetes mellitus also receiving metformin over 24 weeks.
- GL-ASP (Gan & Lee Insulin Aspart biosimilar) / Gan & Lee Pharma
[VIRTUAL] Proposed biosimilar insulin aspart (GL-ASP) shows pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to US-licenced and EU-authorised insulin aspart (Rome Hall) - Jul 13, 2021 - Abstract #EASD2021EASD_756;
P1
The efficacy, safety, and immunogenicity of GL-ASP matched that of NN-ASP in patients with type 2 diabetes mellitus also receiving metformin over 24 weeks. GL-ASP demonstrated both PK and PD bioequivalence and similar safety profile to US-ASP and EU-ASP formulations.
- || Rapilin (Gan & Lee Insulin Aspart biosimilar) / Gan & Lee Pharma, Sandoz
New P1 trial: PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog (clinicaltrials.gov) - Jan 22, 2020
P1, N=36, Completed, Sponsor: Gan and Lee Pharmaceuticals, USA