With rising costs and an ever-growing pipeline of specialty therapies, biosimilars offer a more affordable alternative to costlier biologics. However, uncertainty surrounding regulation and a lack of familiarity with these therapies have made it difficult to effectively integrate biosimilars into clinical practice.
 
A session held at the 2018 American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition addressed some of the key issues and considerations for pharmacists surrounding biosimilar use in oncology care. The session was led by Ali McBride, PharmD, MS, BCPS, BCOP, FASHP, who is the clinical coordinator of Hematology at the University of Arizona Cancer Care Center, and Sandra Cuellar, PharmD, BCOP, clinical assistant professor at the University of Illinois at Chicago College of Pharmacy.
 
In the oncology space, biosimilars’ similar efficacy to the originator products make them a cost-effective option for patients who are often facing expensive treatments. However, when it comes to therapeutic biosimilars, clinicians may still have some reservations about uptake.
 
According to the presentation, biologics are estimated to account for 50% of US prescription drug expenditure in 2018. The FDA has made efforts to encourage the development of biosimilars, highlighted by the release of its Biosimilar Action Plan in June. In 2018, a total 6 biosimilars have been approved so far, which is twice as many as in 2016. According to the presentation, the approval of these drugs will have a huge impact on cost for the practice, cost for the patient, and reimbursement.  
 
Currently approved oncology products include biosimilars to Procrit, Neupogen, Neulasta, Avastin, and Herceptin. Most recently, the FDA approved Truxima, a biosimilar to Rituxan (rituximab) and the first biosimilar approved for non-Hodgkin's lymphoma. However, even after approval, many biosimilars face legal barriers when a patent has not been expired, which can delay availability.
 
Interchangeability remains a barrier to uptake. Without an interchangeability designation from the FDA, pharmacists are unable to substitute the product without intervention of the prescriber. Interchangeability designation requires higher standards than biosimilarity alone, but requirements and trial design for testing are not finalized. Many laws addressing pharmacy-level substitution vary from state to state, making it imperative for providers to be aware of their state’s biosimilar laws.
 
When asked if they knew whether their state had biosimilar legislation, only 12 audience members raised their hands. Being aware of the information passing through state legislature is key, Dr McBride emphasized, especially if you’re working with health systems across state lines.
 
As new trials and guidance become available, biosimilar interchangeability will continue to become a larger discussion, according to the presentation. 
 
Additionally, Dr McBride recommended the Purple Book as a go-to list for biologics and biosimilars approved by the FDA. The list provides information such as date of approval, approval pathway, interchangeability designation, biosimilar status, and exclusivity expiration state.
 
Overall, McBride emphasized a notable lack of awareness surrounding these therapies, underscoring the need for education as a key component to improve biosimilar uptake. Pharmacists can engage patients by providing accessible education about biosimilar therapies. Talking to patients about the effect on access to treatment, insurance coverage, and out-of-pocket cost can especially help drive awareness.
 
“When you talk to the patient about cost difference, they become much more aware and knowledgeable because there is a cost saving as well,” McBride said.
 
In addition, continued education with health care providers is also important to promoting biosimilar use. A 2016 survey of physicians cited in the presentation found that almost half were unaware of biosimilar approvals. Pharmacists can work to educate physicians by providing easy access to current clinical information on biologic therapies, including therapeutic guidelines, clinical trial results, and adverse effects.
 
As biosimilar development continues to grow, pharmacists will be essential in transitioning both clinicians and patients alike in the use of these therapies. 

Reference

1. Cuellar S, McBride A. Biosimilars in Supportive and Therapeutic Care: Key Issues and Considerations for Pharmacists. Presented at: 2018 ASHP Midyear Clinical Meeting and Exhibition. December 2-6, 2018. Anaheim, California.