Biosimilars: A Virtuous Cycle of Sustainability and Innovation.

A biosimilar is a biological medicinal product developed to replicate a licensed originator-i.e., the reference product-with which it shares quality, efficacy, and safety. Marketed following expiry of the reference product's patent protection, biosimilars introduce competition that benefits patients and foster sustainability. In addition to such sustainability of healthcare systems, biosimilars confer a less widely recognized yet equally important benefit: they stimulate innovation. The European regulatory framework, pioneered by the European Medicines Agency and reinforced by other reference regulatory bodies, has unlocked this innovative potential. This paper examines how the development, manufacturing, commercialization, and clinical use of biosimilars generate advances in healthcare delivery. Drawing on available evidence and market experience, it proposes a classification of biosimilar-driven innovation into three domains: pharmaceutical innovation, technological innovation, and therapeutic innovation. Benefits wholly or partially attributable to biosimilars encompass both incremental and disruptive improvements within each domain. These include, for instance, the reinvestment of resources into novel therapies and technologies; therapeutic paradigm shifts supported by evidence and increasingly reflected in clinical guidelines; and enhanced formulations and delivery devices. Although relevant to all healthcare stakeholders, this paper is primarily directed at physicians. As key facilitators of biosimilar adoption, they will find that the innovative aspects of these medicines offer both compelling arguments to support broader prescribing and practical examples of how biosimilars can enhance clinical practice and improve patient outcomes.