The formulary process for biosimilar additions at a comprehensive cancer center

Abstract

Biological products may be used to diagnose, prevent, treat, and cure diseases and medical conditions, including cancer. Biosimilar agents, approved under an abbreviated 351(k) pathway, continue to increase in number and market share for biologic agents, especially for cancer care. Although biosimilars offer the potential for improved access to care, their introduction to the marketplace has created significant disruption. It is imperative that health systems providing care to patients with cancer develop a well-defined process to address the challenges associated with biosimilars. This descriptive article outlines pharmacy considerations for biosimilars and describes the current practices at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University. Biosimilars have and will continue to significantly impact oncology care. Organizations must understand the clinical, operational, and financial challenges associated with the use of these products.