The FDA defines a biosimilar as “a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.” In 2015, the FDA approved filgrastim-sndz as the first biosimilar product. Currently, there are now 39 biosimilar products that are FDA-approved.

Recently, four interchangeable biosimilar products were approved by the FDA: Semglee (insulin glargine-yfgn), Rezvoglar (insulin glargine-aglr), Cimerli (rambizumab-eqrn), and Cyltezo (adalimumab-adbm). Interchangeable biosimilars meet additional requirements, which include that the product is expected to produce the same clinical results as the reference product in any given patient, the patient can safely and effectively switch between the interchangeable agent and the reference product without any concerns, and the interchangeable product may be substituted for the reference product without the involvement of the prescriber.

Pharmacists are often charged with making recommendations for formulary additions of biosimilars in an attempt to reign-in drug expenditures. The choice of a biosimilar should be based on more than just drug acquisition cost.

The need for guidance in this drug selection process has led to the development of a model that can be used by pharmacists to select a “best value” biological medicine, i.e., focusing beyond a product’s price to base drug selection on the broader value of the product. The authors of this paper acknowledge that pharmacist experience difficulties with formulating and applying criteria besides price in the selection of off-patient biologicals and biosimilars. They developed a practical model to aid pharmacists and clinicians with the “best value” biological selection process. This process involves three consecutive steps, which include identifying criteria to be used in decision-making, weighing the importance of each criterion, and developing a scoring system to evaluate biological candidates.

Criteria involved in decision-making can be further divided into product-driven criteria, service-driven criteria, and patient-driven criteria. Among the product-driven criteria are technical product features (e.g., availability of numerous strengths, product administration aspects including the availability of multiple formulations or differences in infusion time, the need for reconstitution, flexible storage conditions, and error-reducing packaging); the authorization and reimbursement state of therapeutic indications as not all biosimilars have the same indications as the originator drug; and real-world product experience. Unlike in Europe, in the United States biosimilars are not allowed to have different strengths, dosage forms, or routes of administration than the originator product.

Service-driven criteria include supply conditions (which can include anticipating and minimizing drug shortages whenever possible); the availability of value-added services (which can include therapeutic drug monitoring, training, and education of health professions; and support for clinicians); and promoting and maintaining sustainability and environmental issues.

Patient-driven criteria include product-user friendliness, which can enhance adherence, and offering patient support programs, which can be in the form of pharmaceutical assistance programs and/or patient education.

Once the criteria have been established, healthcare facilities can prioritize and weigh each criterion to best meet their mission and needs. The weight given to each criterion should be proportional to their importance. This is a dynamic process. The authors also provide the reader with an overview of possible questions that are relevant to the selection of a “best value” biological. These questions align with the three classes of criteria.

This paper can serve as a valuable resource for pharmacists who are involved in formulary decision-making for biological and biosimilar agents.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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