Biosimilars have rapidly proliferated in the cancer care landscape, leaving many providers unclear about the full impact these products will have on the care they deliver to patients. “American Society of Clinical Oncology Statement: Biosimilars in Oncology,” published in the Journal of Clinical Oncology, examines a range of issues to help ASCO members better understand the impact of biosimilars on oncology care.
To date, the Food and Drug Administration (FDA) has approved eight biosimilars for use in the United States, two of which were approved to treat cancer, and a third was approved as a supportive care agent in the cancer setting. Given the expiration of several biologic drug patents, a wave of biosimilars is expected, and cancer treatments will likely comprise a significant number of those approvals.
ASCO’s statement on biosimilars 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.
While many biosimilars will be available in oncology in the next several years, their impact on patient care will depend largely on patient and provider acceptance—based on an adequate understanding of the safety and efficacy—of these agents. ASCO’s statement affirms the society’s commitment to enhancing confidence in biosimilars through provider education and advocacy for federal and state policies that ensure efficient approval, unrestricted access, and appropriate use of biosimilars.
Read the full statement.
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