American Society of Clinical Oncology Issues Statement on Biosimilars

April 23, 2018

Biosimilars Team

A new statement from the American Society of Clinical Oncology (ASCO)—“Biosimilars in Oncology”—provides education and guidance to the oncology community on the assessment of the safety and efficacy of biosimilars in the cancer setting. The statement appears in the April 20, 2018, issue of the Journal of Clinical Oncology.

The authors note that a wave of biosimilars is expected in the United States, and cancer treatments are likely to consist of a significant proportion of the approved biosimilars. Although access to biosimilars could potentially reduce the cost of cancer therapies, the authors explain that inconsistent use and a lack of understanding of the terminology, evolving regulatory guidance, and questions about how biosimilars may be prescribed and dispensed, have contributed to an uncertain environment for all stakeholders. The statement offers guidance on: (1) naming, labeling, and other regulatory considerations, (2) safety and efficacy, (3) interchangeability, switching, and substitution, (4) value, and (5) prescriber and patient education.

“Biosimilars will play an important role in the future care of patients with cancer and will improve access to valuable medicines,” the authors conclude. “Whereas many biosimilars in oncology will be available in the next several years, their use and effect on patient care and health care costs will largely depend on patient and provider acceptance on the basis of an adequate understanding of the safety and efficacy of these agents in cancer care. This statement affirms ASCO’s commitment to ensure the availability of biologics that are necessary in the delivery of high-quality, high-value care. To enhance patient and provider confidence in biosimilars, it is necessary to educate oncology providers and continue to advocate for federal and state policies that ensure the efficient approval, unrestricted access, and appropriate use of biosimilars.”

Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14.