Background It has been 6 years since the first biosimilar was approved for use in the European Union (EU). Given the likelihood that biosimilar monoclonal antibodies will be approved in Europe in the near future, it is timely to review the formulary selection criteria for biologicals and biosimilars.
The European Medicines Agency (EMA) has issued guidelines that define the regulation of biosimilars in Europe and recommend approaches to establish biosimilarity. However, several questions regarding the assessment of biosimilars for formulary inclusion remain unanswered, including those related to manufacturing and drug supply.
Purpose To aid hospital pharmacists in developing evaluation criteria for biosimilars under consideration for formulary inclusion.
Materials and Methods EU and United States biosimilar legislation, peer-reviewed literature, public data, EMA guidelines and formulary decision-making practises were reviewed to identify key considerations and evaluation criteria for including biosimilars in a formulary.
Results Biosimilars may differ in certain characteristics from their reference product and, therefore, require more extensive evaluation during formulary consideration than small-molecule generics. Recent drug shortages and stockouts throughout Europe underscore the need to evaluate manufacturer reliability and supply chain considerations in formulary reviews of biosimilars. Indications approved for the reference product may not be approved for the biosimilar and should be considered during formulary review. Therefore, we propose a checklist that includes criteria for product evaluation and manufacturer-related parameters, such as differences in administration devices, drug availability, inventory turns, history of shortages, recalls, inventory levels, manufacturing redundancy and supply chain security.
Conclusions Ensuring a stable, reliable supply of quality products is a critical component of healthcare. Product, manufacturer, and pharmacoeconomic information should be considered in formulary decision-making for biosimilars. A checklist of key product- and manufacturer-related information will be promoted thorough evaluation of biosimilars, permitting educated decisions regarding formulary inclusion.
No conflict of interest.
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