Category: Fellows Posters
The release of FDA’s Purple Book has led institutions to consider replacing biologic formulary products with their biosimilar alternative. A lack of standardized knowledge of biosimilars frequently delays their evaluation and may result in a loss of revenue that could be prevented if prompt and thorough reviews were implemented. Reviews such as these are performed at our institution during monthly Pharmacy and Therapeutics Committee meetings, where interdisciplinary leaders discuss formulary additions. The purpose of our project is to describe the development of a template with components necessary to evaluate the safety and efficacy of biosimilars to inform decision making.
A literature search was performed to determine factors that are important to consider when introducing a biosimilar to formulary. Articles were analyzed to determine various impacts a biosimilar introduction could have on stakeholders. Stakeholders included the pharmacy department, medical department, institution, and patient population. Literature evaluations were also performed to identify unique criteria for comparing a biosimilar to its originator. Per institutional recommendations, biosimilars being introduced into formulary were required to be designated as a “biosimilar” in the FDA’s Purple Book prior to evaluation. Important factors for evaluating the safety and efficacy of biosimilars which were identified by our literature search informed the development of a biosimilar review template.
The following components were determined to be important considerations when comparing a biosimilar to its originator at our institution: differences in labeled indications, literature evaluation of supporting documents used by the FDA, differentiation of biosimilar in the electronic medical record, manufacturer reliability and reputation, comparison of packaging and labeling, differences in dosing for approved indications, acquisition cost, insurance reimbursement, prior authorizations, and availability of product outside of institution. A template was created based on the identified components to encompass possible impacts a biosimilar could have when replacing an originator product. The template was piloted when reviewing two new chemotherapy biosimilars being introduced into our hospital formulary. These reviews were presented at the Pharmacy and Therapeutics Committee meeting as well as at the Oncology Performance Improvement Committee meeting. Both reviews provided relevant information and were structured to include objective comparison of both biosimilar and originator products. This format helped inform decisions for formulary inclusion and confirmed the utility of the template. Members of both Committees provided positive feedback on the template which was also endorsed and approved by the Medication Safety Subcommittee.
The development of a template provided a systematic approach to reviewing and evaluating biosimilars for formulary inclusion. Based on the pilot, the template will be utilized for all future reviews of biosimilars.