PHP19 - Management of Biosimilars: Key Considerations for Pharmacists in Patient Care

Abstract

The US market for Biosimilars (BS) is expanding. The inherent differences in living systems contribute to the complexity of replicating the biologics and manufacturing BS. Pharmacists being one of the first healthcare providers that the patients approach for drug related issues, it is essential for them to be aware of BS management. The goal of this project is to serve as a primer to the process of discovering the role of pharmacists in the management of safety and efficacy problems associated with BS. This project explores and summarizes the key considerations for the pharmacists for better management of BS in their everyday practice. A systematic and comprehensive review of literature from EBSCO, ScienceDirect, ProQuest Direct, and Pub Med was conducted. Information from relevant articles and studies published between 2009--present was selected. Articles were grouped according to three areas of focus: formulary management, pharmacy substitution laws, and medication non-adherence issues. A narrative analysis was used to synthesize the results. The review identified twenty eligible full-text articles. To substitute biologics for less expensive BS, the pharmacists have to abide by the interchangeability provisions of FDA and be aware of legal parameters related to informing the prescriber and maintaining records. To evaluate the inclusion of a BS in the formulary, the pharmacists need to evaluate the safety and efficacy, manufacturer considerations, and hospital and patient considerations. Moreover, having an understanding of the factors that affect patient adherence will help pharmacists promote adherence and prevent adverse drug events. To ensure the proper use and minimize risks associated with BS, pharmacists’ understanding and knowledge of the substitution laws, formulary management, and adherence concerns are necessary. These criteria can serve as the base for optimal outcomes, but the final approach to care needs to be customized on individual product and patient basis.