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Evaluation of Biosimilars for Formulary Inclusion: Factors for Consideration by P&T Committees
P&T Community (10/01/15) Vol. 40, No. 10, P. 680; Ventola, C. Lee
Healthcare professionals (HCPs), especially those in the pharmacy and therapeutics (P&T) arena, will be vital for encouraging the adoption of biosimilars in the United States. These individuals can lead the appropriate adoption and use of biosimilars by applying formulary and practice management tools and principles. Biosimilar formulary review will look at clinical parameters, such as clinical data and immunogenicity, product characteristics such as nomenclature and labeling, and institutional considerations such as substitution, costs, provider education, and tracking. When evaluating biosimilars, pharmacy and therapeutics providers should also understand the clinical implications of the drugs' production. Biologics manufacturing involves complex processes, including identifying and cloning a targeted gene sequence. In addition, it is important to recognize that biosimilars have unique characteristics compared with small-molecule generic drugs. P&T providers should also understand the differences in the approval pathways for biologics to better evaluate the labeling of each drug. The use of biosimilars will require HCPs to be fairly comfortable about prescribing them, but research shows that clinicians still have a wide range of understanding about the drugs.
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