Pharmacists are the recognized experts in pharmacotherapy. With the recent introduction of biosimilar agents into the US market, pharmacists are poised to play a pivotal role in evaluating their risks versus benefits within the framework of cost containment.
Purpose
This article provides hospital pharmacists with the necessary information on the principles surrounding the development, approval process, and use of biosimilars.
Methods
Information contained in this article enables hospital pharmacists to identify concerns relating to biosimilars, implement educational components, and successfully evaluate biosimilars for the addition to the formulary. Additionally, this article reviews the European experience with biosimilars, the US Food and Drug Administration approval process, and postauthorization safety and pharmacovigilance programs.
Conclusion
It is important to educate health care providers about the differences between biosimilars and their reference biologics. The adoption of biosimilars is necessary to control long-term costs of biologics, increase patient access to care, and encourage innovation.
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