Biosimilars, or biologics that are highly similar to an FDA-approved innovator biologic (the branded product), represent a total future savings potential of $54 billion between 2017 to 2026. However, actualizing these savings will require adoption at a much higher rate than we have seen to date.
While some health systems have fully adopted the use of biosimilars, others have been slower due to a range of obstacles.
Below, we highlight strategies for overcoming the four most common barriers to adoption.
1. Improve education
Until prescribers and pharmacists gain confidence in biosimilars, we cannot expect broad utilization. An important early step is for pharmacy leaders to provide prescribers and pharmacists with educational tools and training, such as those created by the FDA and professional societies. These tools should address common misconceptions (e.g., whether biosimilars are inferior to innovator biologics—they aren’t!) and highlight key information about approvals, efficacy, and safety.
Here are a few areas of focus:
- The rigor of the FDA approval process for biosimilars;
- The breadth of randomized controlled trials demonstrating similar efficacy and safety compared to innovator biologics; and
- The array of randomized controlled trials demonstrating the safety of switching from an innovator biologic to a biosimilar without impacting therapeutic outcomes.
2. Develop shared understanding of naming conventions
Previously, biosimilars could be identified by the four-letter suffix appended to the end of core product names (i.e., trastuzumab-anns is comprised of the core name “trastuzumab” and the four-letter suffix “-anns”). However, under recent updates to the FDA guidance for nonproprietary naming of biologic products, all biologics should receive a four letter suffix on the end of the core name, despite electronic health record systems’ inability to accept these four letter suffixes.
Related article: The State of Biosimilars in 2019
Further complicating matters, biosimilars also receive a branded name in addition to the nonproprietary core product name. This branded name is unrelated to the innovator biologic’s brand name (i.e., Herzuma, Kanjinti, and Ogivri are all biosimilars of Herceptin). These naming conventions make the process of identifying and selecting a biosimilar complicated. Therefore, great care should be taken by health systems to address the best way to identify and enter biosimilars in EHR and prescribing systems.
One way of addressing this is to use an “agnostic” name for physician ordering, followed by the selection of the “preferred product” in the pharmacy module, based on approved substitution policies. For example, a physician may prescribe a patient “infliximab” then the pharmacy module selects the health system preferred infliximab product (infliximab or one of its biosimilars, infliximab-abda or infliximab-dyyb).
3. Create therapeutic interchange and substitution policies
Currently, no biosimilar has been approved as an “interchangeable biosimilar,” a designation that would allow it to be substituted for an innovator biologic without prescriber consultation.