Biosimilars and Future Biotherapeutics

Cost-Effectiveness and Health Economics of Biosimilars

Biosimilars, which are highly similar to already approved originator biologics with no clinically meaningful differences in terms of safety, purity, and potency, have emerged as a critical tool in reducing the financial burden on healthcare systems worldwide. The high cost of biologics has been a persistent challenge, often limiting access to life-saving treatments for patients with chronic and complex conditions such as cancer, autoimmune diseases, and rare genetic disorders. Biosimilars address this gap by increasing competition in the biologics market, leading to price reductions and expanded patient access.One of the major economic advantages of biosimilars is their ability to lower direct drug costs. Although the development and manufacturing of biosimilars involve significant investment, these costs are still considerably lower than those required for developing novel biologics, primarily because biosimilars bypass much of the early-stage discovery and preclinical work. This economic efficiency is reflected in their market pricing, with biosimilars typically being 15–30% less expensive than their reference products. In large-scale healthcare systems, such cost savings translate into substantial financial relief, enabling the reallocation of resources to other areas of patient care, research, and public health initiatives.