Regulatory and clinical aspects in biosimilar medicines: comparability, extrapolation, interchangeability, and safety
摘要
Biological medicines have transformed modern therapeutics, enabling effective treatment for various chronic and severe conditions such as diabetes, cancer, and rheumatoid arthritis. Since their introduction in the 1980s, these innovative treatments have significantly improved patient outcomes and life expectancy. With the expiration of exclusivity rights for many biological drugs, biosimilars have emerged as cost-effective alternatives. Biosimilars are biologically derived medicines that demonstrate high similarity to their reference products, with no clinically meaningful differences in quality, safety, or efficacy, as confirmed through rigorous comparability studies. The development of biosimilars has enhanced access to biological therapies by reducing treatment costs, thus alleviating financial burdens on healthcare systems. Since the first biosimilar approval in 2006, over 80 biosimilars have been authorized in Europe, facilitating broader adoption. Real-world clinical data support their equivalence to originator biologics in therapeutic performance, reaffirming the reliability of pre-approval comparability assessments. Biosimilars are now integral to modern healthcare, offering effective, safe, and affordable treatment options for patients globally. Three distinct categories of biological substances and their respective biosimilars—growth hormone, monoclonal antibodies, and insulin analogs and insulin—were analyzed to integrate the discussed concepts and comprehensively evaluate their impact on the healthcare market. These substances represent different stages of regulatory approval by the European Commission: one approved over a decade ago, one recently approved, and one currently under development and regulatory evaluation.