Unfortunately, drug shortages are common and have been the subject of numerous articles in recent years.^1,2 Due to their highly specialized manufacturing process, sterile injectables make up a large percentage of these shortages. The number of new shortages has decreased overall since 2011.²

In one survey, 99% of pharmacy directors reported at least one oncologic drug shortage during the prior year, with the following consequences:³

A 2010 survey of 353 pharmacy directors conducted by the American Society of Health-System Pharmacists (ASHP) found that the time and labor their staff spends managing drug shortages were significant, and the information available to manage drug shortages was suboptimal.⁴

To avoid treatment delays and unplanned switching between biologics during the course of treatment, it is important to consider a manufacturer’s history of shortages and recalls related to quality concerns, and evaluate its capability to maintain adequate production and stock to support demand. It is also important to consider the robustness of the manufacturer’s supply chain when evaluating biosimilars.⁵