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Recently, Gan & Lee Pharmaceuticals published the results of the Phase I clinical trial of three insulin products – Basalin®️ (insulin glargine), Prandilin®️ (insulin lispro), and Rapilin®️ (insulin aspart) - in the peer-reviewed journal Diabetes, Obesity and Metabolism. Founded in 1999, Diabetes, Obesity and Metabolism is an interdisciplinary journal of clinical and experimental pharmacology and therapeutics in any aspect of metabolic and endocrine disease. As an international prestigious scientific journal, its latest impact factor in 2023 is 5.8, JCR region 1, thereby having wide influence in the industry 1.
Gan & Lee Pharmaceuticals' insulins glargine, lispro and aspart have been on the market in China for many years and are currently being submitted for marketing approval in Europe and the United States as biosimilar insulins. Per the local regulations, the proposed biosimilars must demonstrate that they have highly similar pharmacokinetic (PK) and pharmacodynamic (PD) characteristics to the reference drugs marketed in the EU and the US. To this end, Gan & Lee Pharmaceuticals conducted three Phase I, randomized, double-blind, triple-crossover, euglycemic clamp* clinical trials in Europe to demonstrate the bioequivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) between Gan & Lee's three biosimilar candidates (insulin glargine, lispro, and aspart) and the respective reference products sourced from the EU and the US (Lantus®️, Humalog®️, and NovoLog®️/NovoRapid®️). The Primary PK endpoints were the total area under the PK curves (AUCins.total) and maximum insulin concentrations (Cins.max); the Primary PD endpoints were the total area under the glucose infusion rate curve (AUCGIR.total) and maximum glucose infusion rate (GIRmax).
Bioequivalence to both EU- and US-reference products were demonstrated for all three GL insulins. Least squares mean ratios for the primary PK/PD endpoints were close to 100%, and both 90% and 95% confidence intervals were within 80%–125% in all three studies. There were no noticeable differences in the safety profiles between test and reference insulins, and no serious adverse events were reported for the Gan & Lee’s insulins. In conclusion, all three proposed Gan & Lee’s insulin biosimilars are bioequivalent to their EU- and US-reference products 2.
Dr. Zhongru Gan, Founder of Gan & Lee Pharmaceuticals and corresponding author of the article, said, "These clinical studies conducted in Europe have strongly demonstrated the biosimilarity of Gan & Lee's three domestically marketed insulin products to the originator reference products (Lantus®️, Humalog®️, and NovoLog®️/NovoRapid®️), which is another proof of the high quality and reliability of Gan & Lee's products. All three products of Gan & Lee, Basalin®️, Prandilin®️, and Rapilin®️, have submitted BLA applications to the US FDA in the first half of 2023 and have been formally accepted by the authority. Meanwhile, the marketing application for insulin glargine Basalin®️ was formally accepted by the EMA in August 2023 and is now under the scientific review phase. We look forward to the early launch of these three insulins in Europe and the United States to bring benefits to more patients with diabetes".
*Euglycemic Clamp Study: a quantitative method for detecting insulin secretion and insulin resistance, and is considered the "gold standard" for evaluating the body's insulin response to glucose.
Link to the article：
2. Chen W, Lu J, Plum-Mörschel L, et al. Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU- und US-sourced reference insulins [published online ahead of print, 2023 Sep 21]. Diabetes Obes Metab. 2023;10.1111/dom.15281. doi:10.1111/dom.15281
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