An Institutional Guide for Formulary Decisions of Biosimilars

Abstract

Biologics have changed the landscape for the management of many debilitating chronic diseases but account for a significant expenditure of medications globally. Fortunately, advances in technology paved the way for the introduction of biosimilars, which are highly similar to the originator biologics. In the quest to reduce the budget impact of biologics, organizations have begun to adopt biosimilars. Institutions evaluating biosimilars for inclusion in the hospital formulary must make informed formulary decisions by conducting a thorough review of key elements for evaluation of biosimilars and address the multidimensional aspects during the selection process of different biosimilar products. Therefore, we aim to present an institutional guide of these elements to inform formulary decisions. These key elements include biosimilar evaluation for formulary addition; regulatory approval; substitution, interchangeability, and switching; extrapolation; product characteristics, manufacturing, and supply chain issues; pharmacoeconomic evaluations; traceability, nomenclature, and coding; education; and pharmacovigilance.

A Formulary Management Group Consensus

“…Biosimilar switching provides a key opportunity in cost savings; however, issues that institutions should consider when contemplating a switch to a biosimilar include the following. [ 35–38 ]…”

Comparison of Biosimilar Filgrastim with Innovator Fligrastim for Peripheral Blood Stem Cells Mobilization, Collection of CD34+ Stem Cells, and Engraftment in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation: A Single-Center Experience

“…Biosimilar products are generally approved based on the clinical trials in one indication and then extrapolation is used to include the other indications of the originator based on the totality of the evidence gained from one indication. Hence, there might be some concerns regarding the long-term evaluation of biosimilars, particularly the limited experience with these products in terms of efficacy, safety, and immunogenicity at the time of approval [ 4 , 5 ]. For instance, use of biosimilar filgrastim (Zarzio ® ) in mobilization of CD34+ve stem cells in both allogenic and autologous stem cell transplant patients is an extrapolated indication.…”

An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare

“…It is known that between 30 and 50% of new medicines approved in Europe are currently biosimilar [ 13 ]. By August 2022, 1775 biological products were licensed in the US market, of which 82 were biosimilar [ 14 ].…”