Zeina Nahleh1, Gary H Lyman2, Richard L Schilsky3, Douglas E Peterson4, Scott T Tagawa5, Mariana Chavez-MacGregor6, R Bryan Rumble7, Shilpi Gupta8. 1. Cleveland Clinic Florida, Weston, FL. 2. Fred Hutchinson Cancer Research Center and the University of Washington, Seattle, WA. 3. University of Chicago, Chicago, IL. 4. UConn Health, Farmington, CT. 5. Weill Cornell Medicine/Cornell University, New York, NY. 6. University of Texas MD Anderson Cancer Center, Houston, TX. 7. American Society of Clinical Oncology, Alexandria, VA. 8. Morristown Medical Center, Morristown, NJ.
Abstract
PURPOSE: The increased number and expanded utilization of biosimilars raise important considerations for their safe and appropriate use in oncology practice. This report provides an update on currently approved oncology biosimilars and identifies current knowledge gaps in the management of patients with cancer. METHODS: An Expert Panel was convened to review the medical literature and to provide a practical summary of currently approved biosimilar therapeutics for cancer treatment or supportive care in the United States. RESULTS: A total of 17 cancer or cancer-related biosimilar products have been approved by the US Food and Drug Administration since 2015. Despite years of clinical experience with oncology biosimilars, variance in their use persists. ASCO supports that biosimilars and reference products are considered equally efficacious for the purpose of inclusion in ASCO clinical practice guideline recommendations. CONCLUSION: The use of biosimilars might provide competitive, lower-cost alternatives to biologics used in cancer care, and specific mention in ASCO guidelines and other evidence products is supported where appropriate.
PURPOSE: The increased number and expanded utilization of biosimilars raise important considerations for their safe and appropriate use in oncology practice. This report provides an update on currently approved oncology biosimilars and identifies current knowledge gaps in the management of patients with cancer. METHODS: An Expert Panel was convened to review the medical literature and to provide a practical summary of currently approved biosimilar therapeutics for cancer treatment or supportive care in the United States. RESULTS: A total of 17 cancer or cancer-related biosimilar products have been approved by the US Food and Drug Administration since 2015. Despite years of clinical experience with oncology biosimilars, variance in their use persists. ASCO supports that biosimilars and reference products are considered equally efficacious for the purpose of inclusion in ASCO clinical practice guideline recommendations. CONCLUSION: The use of biosimilars might provide competitive, lower-cost alternatives to biologics used in cancer care, and specific mention in ASCO guidelines and other evidence products is supported where appropriate.
Authors: Elizabeth Lerner Papautsky; Martha Carlson; Sheila M Johnson; Hannah Montague; Deanna J Attai; Maryam B Lustberg Journal: Breast Cancer Res Treat Date: 2022-05-14 Impact factor: 4.624