Wen Jimmy, Razick Adam, How-Volkman Christiane, Bernstein Ethan, Nadora Denise, Truong Alina, Razick Daniel, Akhtar Muzammil, Karabala Muhammad, Frezza Eldo
College of Medicine, California Northstate University College of Medicine, Elk Grove, California, USA.
Department of Psychology, University of California, Los Angeles, California, USA.
Diabetes Obes Metab. 2025 Mar;27(3):1113-1122. doi: 10.1111/dom.16110. Epub 2024 Dec 9.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are at the forefront of treating the global health crisis of diabetes mellitus (DM) and obesity. However, the demand for GLP-1 RAs has far outstripped its supply and comes with a high monthly cost. Thus, the development of GLP-1 RA biosimilars can potentially address these barriers by providing greater access to medications that provide clinical outcomes similar to those of the reference products. A narrative review was conducted to examine the current and future developments for GLP-1 RA biosimilars. Liraglutide and semaglutide are the predominant GLP-1 RAs being investigated for the development of biosimilars. Preliminary liraglutide biosimilar comparisons to reference liraglutide have demonstrated similar clinical efficacy and safety profiles. Semaglutide and beinaglutide biosimilars are currently under investigation as well. With the growing popularity of GLP-1 RAs, accessibility and affordability remain a challenge as monthly costs without insurance for liraglutide, semaglutide and tirzepatide are $1418, $892, and $974 respectively. This trend negatively impacts patients with obesity and DM as well as patients who can utilize it for off-label indications for conditions that benefit from weight loss such as obstructive sleep apnoea and non-alcoholic fatty liver disease. A substantial number of pharmaceutical and healthcare companies worldwide are conducting clinical trials on their GLP-1 RA biosimilars. Preliminary results from liraglutide biosimilars are promising, and several semaglutide biosimilars are currently being investigated. Future research should focus on conducting comparative head-to-head trials to determine the clinical outcomes between biosimilars and reference products.
胰高血糖素样肽-1受体激动剂（GLP-1 RAs）处于治疗糖尿病（DM）和肥胖这一全球健康危机的前沿。然而，对GLP-1 RAs的需求远远超过了其供应，且每月成本高昂。因此，GLP-1 RA生物类似药的开发有可能通过提供更多获得临床疗效与参比产品相似的药物的途径来解决这些障碍。本研究进行了一项叙述性综述，以考察GLP-1 RA生物类似药的当前及未来发展情况。利拉鲁肽和司美格鲁肽是正在进行生物类似药开发研究的主要GLP-1 RAs。利拉鲁肽生物类似药与参比利拉鲁肽的初步比较已显示出相似的临床疗效和安全性。司美格鲁肽和贝那鲁肽生物类似药目前也在研究中。随着GLP-1 RAs的日益普及，可及性和可负担性仍然是一个挑战，因为利拉鲁肽、司美格鲁肽和替尔泊肽在无保险情况下的月费用分别为1418美元、892美元和974美元。这种趋势对肥胖症和糖尿病患者以及可将其用于非标签适应证（如阻塞性睡眠呼吸暂停和非酒精性脂肪性肝病等受益于体重减轻的疾病）的患者产生了负面影响。全球大量制药和医疗保健公司正在对其GLP-1 RA生物类似药进行临床试验。利拉鲁肽生物类似药的初步结果很有前景，目前也正在对几种司美格鲁肽生物类似药进行研究。未来的研究应侧重于进行比较性的头对头试验，以确定生物类似药与参比产品之间的临床疗效。
