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Review
. 2017 Nov-Dec;8(7):688-699.
Epub 2017 Nov 1.

Integrating Biosimilars Into Oncology Practice: Implications for the Advanced Practitioner

Christopher J Campen  1
Affiliations
Review

Integrating Biosimilars Into Oncology Practice: Implications for the Advanced Practitioner

Christopher J Campen. J Adv Pract Oncol. 2017 Nov-Dec.

Abstract

Biosimilar agents are biologic products that have been shown to be "highly similar" to an already approved reference biologic product. Their integration into clinical practice has the potential to significantly decrease costs for patients, health-care systems, and insurance companies. Through legislation, the US Food and Drug Administration (FDA) approved the Biologics Price Competition and Innovation (BCPI) Act in 2009. In 2010, it was signed into law, allowing for an abbreviated pathway for biosimilar approval. This law implemented a framework for development and regulation of biosimilars for manufacturers and provided guidance for the key submission components necessary to achieve final FDA approval. Many factors will influence how biosimilars are integrated into health-care systems and oncology clinics. As biosimilar utilization in the United States expands beyond supportive care, unique challenges will emerge. Patient and staff education will be at the forefront of the successful application of biosimilar agents in oncology, and advanced practitioners will be in a unique position to lead change. The goal of this article is to describe the chemical and clinical nature of biosimilars, review focus areas of interest for biosimilar development in oncology, discuss implementation strategies for biosimilars, and provide techniques for patient education on biosimilars.

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Figures

Table 1
Table 1
Comparison of Generic Drugs vs. Biosimilars
Table 2
Table 2
Common Biosimilar Terminology
Table 3
Table 3
Biosimilar Development and Approval
See this image and copyright information in PMC

References

    1. Bennett Charles L, Luminari Stefano, Nissenson Allen R, Tallman Martin S, Klinge Stephen A, McWilliams Norene, McKoy June M, Kim Benjamin, Lyons E Allison, Trifilio Steve M, Raisch Dennis W, Evens Andrew M, Kuzel Timothy M, Schumock Glen T, Belknap Steven M, Locatelli Francesco, Rossert Jerôme, Casadevall Nicole. Pure red-cell aplasia and epoetin therapy. The New England journal of medicine. 2004;351:1403–1408. - PubMed
    1. Blank C. How new biosimilars will impact the market. Drug Topics. 2017 Retrieved from http://drugtopics.modernmedicine.com/drug-topics/news/how-new-biosimilar....
    1. Camacho Luis H. Current Status of Biosimilars in Oncology. Drugs. 2017;77:985–997. - PubMed
    1. Camacho L H, Pai N. Pharmacovigilance of oncology biosimilars. Journal of Pharmacovigilance. 2015;(S3):1–6.
    1. Center for Drug Evaluation and Research. List of licensed biological products with (1) reference product exclusivity and (2) biosimilarity or interchangeability evaluations to date. 2017 Retrieved from https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsa....

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