There are multiple distinctions in labeling indications between biosimilars and brand products, and pharmacists must become familiar with these to be of maximum service to patients and physicians, according to a review.
The introduction of biosimilars in the US market brings along specific challenges to health system pharmacists, including formulary assessment, implementation, and education of patients and various health system stakeholders, according to a review published in Drugs In Context.
Despite the Biologics Price Competition and Innovation Act (BPCIA) being passed in 2009, the US FDA approved its first biosimilar in 2015. As of February 2020, 24 other biosimilars have been approved while only 11 have launched. In comparison, the European Union has had over 50 biosimilars approved since 2006.
Health system pharmacists ought to carefully review product labels of the biosimilar and its reference product (RP) to understand how differences can affect clinical practice and formulary decisions, researchers note. Some biosimilars and their reference products have differing storage and dosing requirements. “As multiple biosimilars for a given RP enter the market, these activities will become progressively more challenging,” authors said.
Changes in conventional naming practices also have to be taken into account and accurately reflected in electronic medical records. Mistakes in the transition to nonproprietary biologic names could result in errors involving inventory management, pharmacovigilance, and patient safety.
In the United States, an interchangeability designation can only be achieved independently from the initial approval of a biosimilar. Because of this, biosimilars may never achieve interchangeability. In the absence of the designation, “substitution may still occur but only with the documented prescriber, and possibly patient, notification and/or consent, as stipulated by state-level laws,” researchers said.
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