Review Article
Biosimilars in the United States: Considerations for Oncology Advanced Practitioners
Kelley D. Mayden, MSN, FNP, AOCNP®, IAC,1 Paul Larson, MSN, AOCNP®,2 Danielle Geiger, MSN, APRN-NP,3 and Holly Watson, MS, ANP-BC4
1Southwest Virginia Cancer Center, Norton, Virginia; 2Fletcher Allen Health Care, Burlington, Vermont; 3Nebraska Cancer Specialists, Omaha, Nebraska; 4Amgen Inc., Thousand Oaks, California
Authors’ disclosures of potential conflicts of interest are found at the end of this article.
Kelley D. Mayden, MSN, FNP, AOCNP®, IAC, Southwest Virginia Cancer Center, 671 Highway 58 East, Norton, VA 24273.
E-mail: kdunrun@charter.net
J Adv Pract Oncol 2015;6:108–116 |
DOI: 10.6004/jadpro.2015.6.2.3 |
© 2015 Harborside Press®
ABSTRACT
Abstract
Biosimilars will enter the US market soon, potentially lowering costs and increasing patient access to important oncology biologics. Biosimilars are highly similar, but not identical, to their reference product. Subtle variations arise due to their inherent complexity and differences in manufacturing. Biosimilars are not generic drugs. They will be approved through a separate US regulatory pathway—distinct from conventional biologics license applications—based on analytic and clinical studies demonstrating no clinically meaningful differences from the reference product. As policies on US biosimilars evolve, it is important that advanced practitioners receive comprehensive, ongoing education on them, particularly regarding differences from small-molecule drugs; their approval pathways vs. conventional regulatory pathways; evaluation of quality, safety, and efficacy; safety monitoring; and product identification to facilitate accurate safety reporting. Advanced practitioners will play a key role in educating nurses and patients on biosimilars. Nurse education should highlight any differences from the reference product (e.g., approved indications and delivery devices) and should emphasize assessment of substitutions, monitoring for adverse events (e.g., immune reactions), and the need for precise documentation for safety reports. Patient education should address differences between the biosimilar and reference product in administration, handling and storage, and self-monitoring for adverse events.
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