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

Building Trust in Generics and Biosimilar: Strengthening Regulatory Confidence. (PubMed, Malays J Med Sci) - "On 4 March 2025, HRS registered Rapilin 30, Malaysia's first premixed insulin aspart biosimilar, reflecting the growing industry maturity. In the United States, generics and biosimilars generated an estimated USD 467 billion in savings in 2024, demonstrating the economic potential of such medicines. Malaysia's continued adherence to international regulatory standards and collaboration between public and private sectors will be key to sustaining confidence, achieving national pharmaceutical self-reliance and medicine security."

Journal

Sandoz confirms European Commission approval for biosimilars Bysumlog (insulin lispro) and Dazparda (insulin aspart), strengthening position in diabetes (Sandoz Press Release) - "Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults and children, while Dazparda is approved for the treatment of diabetes mellitus in adults, adolescents and children aged one year or more."

EMA approval • Diabetes

On 26 February 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dazparda, intended for the treatment of diabetes mellitus. (European Medicines Agency)

CHMP • Diabetes

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