Review Outlines Challenges of Integrating Biosimilars Into Clinical Practice

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.

Health system pharmacists may also have to come up with proposals supporting a patient’s switch from a reference product to a biosimilar. However, authors point out “there will likely be limited data available on single or multiple switches, and little or no evidence on switching among biosimilars.” To eliminate any potential nocebo effects, biosimilar screening and education among patients may be a useful practice for health system pharmacists.

Cost comparisons with the RP and other biosimilars, reimbursement assessments, payor coverage reviews, and access evaluations should also be taken into account. As new biosimilars of a single RP enter the market, prices could go down. To address this, health system pharmacists may conduct routine re-evaluations of the economic impact of changes in average selling price (ASP) and the commensurate adjustments to reimbursement.

Although some FDA guidance does exist on the implementation of biosimilars into clinical practice, many real-world scenarios have note been addressed, authors note. “Evaluation of patient perspectives during formulary selection should consider the anxiety associated with mandated switching from an effective therapy, potential interruption in therapy, access to holistic support services, and possible cost increases,” authors said.

However, pharmacists are in an ideal position to advance biosimilar education among prescribers, formulary committee members, and patients. Both education and preparedness will be instrumental in successfully managing the introduction of biosimilars in US clinical practices.

Reference

Zlatkus A, Bixby T, Goyal K. Considerations for the US health-system pharmacist in a world of biosimilars [published online February 25, 2020]. Drugs Context. doi: 10.7573/dic.2019-12-1.