The evolution of biosimilar insulins: A review of current formulations and market impact

Abstract

Biosimilar insulins represent a significant advancement in the management of diabetes, addressing the critical need for affordable insulin options. Biosimilars are highly similar to their reference biologic products, maintaining equivalent quality, safety, and efficacy. The rising costs of branded insulin have created access challenges, especially in low- and middle-income countries. The introduction of biosimilar insulins, such as Basaglar and Semglee, offers promising solutions by increasing competition in the insulin market, potentially reducing costs. This review explores the evolution of biosimilar insulins, regulatory pathways, and the scientific rigor behind their development, including pharmacokinetic, pharmacodynamic, and clinical trial assessments. While biosimilars must demonstrate comparability to their reference products, they offer cost savings and improved access without compromising therapeutic efficacy. However, regulatory and market challenges remain, particularly regarding pricing models, which will shape the long-term impact of biosimilar insulins on healthcare systems and diabetes management.