This article presents a quality comparison between the recombinant origin Semaglutide drug substance made by Aurisco and the innovator’s injectable and oral Semaglutide dosage forms, demonstrating the superior quality and suitability of its API to be used in the development of generic versions. New modalities represent 57% of the total projected pipeline value with seven of the top 10 selling biopharma products in 2024 being new modalities. GLP-1 peptides are growing fast in the ranking, expanding beyond diabetes and obesity with new applications being explored in neuro-degenerative diseases, non-alcoholic steatohepatitis, cardiovascular diseases, and renal diseases. In 2024 Semaglutide (Ozempic, Wegovy and Rybelsus) became the top one selling molecule, with close to $30B worldwide sales. Over the next 5 years, projections include 5 recombinant GLP-1 peptides among the top10, contributing to aggregated global sales of close to $100 billion in 2029.
Since the synthesis of the first therapeutic peptide – Insulin – in 1921, remarkable achievements have been made resulting in the approval of more than 80 peptide drugs worldwide. In 1923, insulin became the first commercial peptide drug and has since benefited thousands of diabetes patients to date. However, the original production of human insulin (a peptide with 51 amino acids) could not keep up with the high market demand, and animal-derived insulins, such as bovine and porcine insulin, dominated the insulin market for almost 90 years until they were replaced by less expensive recombinant insulin. Meanwhile, the technologies used for protein synthesis and purification, structure elucidation and sequencing, made substantial progress, thus accelerating the development of peptide drugs, leading to nearly 40 peptide drugs being approved worldwide by 2020, including synthetic peptides such as synthetic oxytocin or synthetic vasopressin.
Recent advances in structural biology, synthetic biology, and new synthetic and analytical technologies have significantly accelerated the discovery process. As of March 2024, there were 119 peptides with FDA approval for therapeutic or diagnostic purposes, with six approved in 2023 alone, with more than 150 peptides in clinical trials and another 400–600 in preclinical studies.
Underpinning the large demand for Glucagon-like peptide-1 (GLP-1) agonists are demographic mega-trends such as an aging population, changing dietary patterns associated with economic development, and sedentary urban lifestyles. Jointly, these patterns contribute to increasing the prevalence of obesity and Type-2 diabetes. Demand has been exceeding supply, which is causing shortages, much driven by social media. GLP-1 receptor agonists have revolutionised how patients manage Type-2 Diabetes and obesity, approaching their physicians requesting a prescription. Amid high cost and limited supply, some patients may seek alternatives to the highly sought-after drugs. In the US, when a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. Until recently, Ozempic and Wegovy have both been listed on FDA’s Drug Shortages list. In 2024, FDA warned against compounded versions of Semaglutide that combine, mix or alter ingredients in ways that are not regulated or approved.
