Biosimilar insulins in diabetes management: A cost-effective shift in therapeutic options

Abstract

Insulin therapy has been crucial in diabetes management since the 1920s. The emergence of biosimilar insulins, developed after the patent expiration of original insulin analogs, represents a major shift in diabetes care. These biosimilars are highly similar to their reference products in terms of safety, efficacy, and immunogenicity. Current biosimilar formulations, including insulin glargine, insulin lispro, and insulin aspart, have shown comparable clinical outcomes to their originator counterparts while offering cost-effective alternatives that improve patient access to treatment. Regulatory bodies such as the Food and Drug Administration and the European Medicines Agency require rigorous evaluation of biosimilars to ensure their safety and efficacy, including analytical, preclinical, and clinical studies. Biosimilar insulins are expected to reduce insulin therapy costs and enhance market competition, further driving innovation in diabetes management. Real-world studies and clinical trials confirm that biosimilar insulins perform equivalently to reference insulins in terms of glycemic control and safety profiles. Despite the complexities of regulatory pathways, the development of biosimilar insulins holds significant promise for the future of diabetes treatment by offering affordable and effective therapeutic options.