1406 - An Exploratory Analysis of Glucagon-like Peptide-1 (GLP-1) Agonists and Biosimilars: A Literature Review

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 similar clinical outcomes as the reference products. 

Design:

A PubMed search was conducted to find relevant articles covering GLP-1 RA biosimilars and their economic impact. A narrative review was conducted to examine the current and future developments for GLP-1 RA biosimilars.

Results:

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 with the former unable to be sold until the patent expires in 2026. With the growing popularity of GLP-1 RAs, the monthly price and demand have drastically increased over the last couple of years. 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 apnea and non-alcoholic fatty liver disease. 

Conclusions:

There are a substantial number of pharmaceutical and healthcare companies across the world 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 the reference products.