Rapilin (Gan & Lee Insulin Aspart biosimilar) / Gan & Lee Pharma, Sandoz - LARVOL DELTA

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

[VIRTUAL] Phase 3 confirmatory study comparing efficacy and safety of proposed biosimilar and reference insulin aspart, combined with metformin, in patients with diabetes (EASD 2021) - "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."

Clinical • P3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

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

PK/PD data • Metabolic Disorders