Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

By Fran L DeGrazio, West Pharmaceutical Services, Inc.

Background

Growth in biologic drugs in the development pipeline of products has led to growth in the use of injectable drug-device combination products. Figure 1 shows this growth exhibited by drugs that have received FDA approval between 2011 - 2020 in the various package/delivery formats.

Risk Considerations Specific to Combination Products

Looking at history, there are several clear examples that justify why special considerations must be given to biologics and combination products. The most important aspect to remember is the fact that nothing, including the biologic drug product, should be evaluated solely as an individual component. Although risks specific to each component must be understood because a system is only as strong as its weakest link, typically issues occur at the intersection of various components of a system.