Case Study
An experienced oncology nurse in a community practice clinic prepares for the arrival of a 65-year-old patient with metastatic breast cancer. She had received doxorubicin hydrochloride (Adriamycin) and cyclophosphamide (AC) the day before and was returning to receive pegfilgrastim-cbqv (Udenyca).
In preparation for the patient, the nurse verifies the order with the charge nurse, queues the medication in the dispensing system, and prints the label for the pharmacist to prepare the medication. The pharmacist quickly discovers instead of pegfilgrastim-cbqv, the nurse queued filgrastim (Neupogen) for administration.
This near miss is a common incident in the community practice setting given its fast pace and evolving prevalence of biosimilar usage.
Biosimilars May Decrease The Cost Of Cancer Care
The trajectory and rising costs of cancer care have led to significant fiscal impact. Various countries spend billions of dollars annually for lifesaving therapies for this illness.1 The United States has therefore prioritized strategies for cost containment as well as to reduce the cost of oncology pharmaceuticals.2 Within the past decade, biosimilar medications have become an essential component in the care of patients with cancer. These drugs have demonstrated quality, efficacy, safety, and immunogenicity that are equivalent to those of other biologic medications.1
A biosimilar is defined by the FDA as a product that is highly similar but not identical to the previously developed (reference) biologic medication. When compared with biologic drugs, they can be approved only if there are no differences in safety or in adverse effect profile.3
By comparison, biologics have been an essential component of cancer care, with higher cost and often associated with restrictions and reserved for later stages of illness. Biosimilar medications have lower costs, accelerated FDA approval, and the ability to be duplicated given their molecular structure.1 These advantages have led to 30% lower cost and decreased the cost of biologics due to the competition they contribute to the pricing market.
A Brief History Of Biosimilars
The first biosimilars were approved in Europe in 2007, followed by those approved in the United States in 2015. In 2009, the Biologics Price Competition and Innovation Act (BPCIA) was developed as a conduit for the FDA for accelerated approval for biologics highly comparable to existing biosimilars.2 This initiative led to prospective trials that evaluated similar drugs to determine the appropriate dose and schedule for its effectiveness. Since the development of BPCIA, biosimilars have become nationally known for being sufficient alternatives to existing biologics. To date, there are 62 biosimilars approved and 21 are used to treat cancer, according to the FDA.
However, despite the evolution of these drugs, there remains a reluctance by providers to order these drugs given their lack of knowledge regarding their efficacy.
In Europe, filgrastim was the first biosimilar to be approved for the treatment of neutropenia for immunocompromised patients with cancer. Since its evolution, there have been 7 biosimilars approved and deemed equivalent through comparative trials. By comparison, pegfilgrastim was approved as a long-acting version of filgrastim, with 13 biosimilars
available in the United States and Europe.1 These expansions have led to increased access for patients as well as 5-fold usage to protect patients from febrile neutropenia, which increases their risk for mortality.
Nurses’ Role In Biosimilar Administration
Nurses play an important role in the administration of biosimilars and the education of patients receiving them. The first role for oncology nurses is to understand the function of biosimilars compared with that of biologics. It is also important that they review the prescribing information to have foundational knowledge of the indications that led to FDA approval.4 Prior to administration, it is essential that these drugs are appropriately verified and not used interchangeably with biologics. The 5 rights of drug administration must be applied specifically, ensuring the right medication for the right patient to validate its appropriateness based on the diagnosis and treatment plan.
“Nurses play an important role in the administration of biosimilars and the education of patients receiving them.” -Stephanie L. Jackson, DNP, MSN, RN, AOCNS, BMTCN
Given the recent FDA approval of these drugs, nurses also play a pivotal role in monitoring adverse effects. And finally, patients and their families must be educated on biosimilar medications so they are aware of pertinent information and important monitoring strategies.5
As seen in the near miss illustrated on the previous page, nurses must ensure all appropriate steps of verification are executed during preparation of high-alert medication. This is especially needed in health care systems that utilize community practice clinics and systems such as Lynx that depend on staff to queue medications in the system for preparation.
REFERENCES
- Abdul Jamsheer PK, Vigneshwaran LV, Senthil Kumar M. Biosimilar in oncology. Texas Journal of Multidisciplinary Studies. 2022;7:145-151.
- Nahleh Z, Lyman GH, Schilsky RL, et al. Use of biosimilar medications in oncology. JCO Oncol Pract. 2022:18(3):177-186. doi:10.1200/OP21.00771
- Review and approval. FDA. December 13, 2022. Accessed October 30, 2024. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580429.htm
- Knoop T. Biosimilars: essentials for oncology nurses. Presented at: 5th Annual School of Nursing Oncology Live; August 6-7, 2021; online webinar.
- Zack E. Nursing roles: clinical implications regarding trends, administration, and education for biosimilars in oncology practice. Clin J Oncol Nurs. 2018;22(5):21-26. doi:10.1188/18.CJON.S1.21-26
