Clinical and Formulary Considerations for Biosimilars

Abstract

The introduction of biosimilars represents an important mechanism by which health care organizations can manage the increasing expense of pharmaceuticals. While intended to occupy a position similar to that of generic versions of small-molecule medications, biosimilars will be governed by a unique regulatory mechanism, given the size, complexity, and variability of the originator biologic drugs. Therefore, the processes by which biosimilars will be evaluated for formulary inclusion and clinical use will be different as well. The biosimilar market is still in the early stages of development and requires further maturation. Therefore, pharmacists can seize the intervening time to assume leadership positions in preparing their organizations and clinical colleagues, including physicians, for the continued development of this new product class. Pharmacists must ensure that an appropriate clinical infrastructure is in place to allow for the safe and effective prescribing, administration, and monitoring of biosimilars. They must also be prepared to differentiate between state regulatory actions concerning biosimilars and the conflicting marketing messages that originator and biosimilar manufacturers are likely to issue. This article provides an introduction to the key formulary considerations required for biosimilar evaluation and use.