Check for updatesASCO Special ArticlesASCO Policy Statement on Biosimilar and InterchangeableProducts in OncologyGladys Rodriguez,MD';Joan Mancuso,MA2;Gary H.Lyman,MD,MPH3;Fatima Cardoso,MD;Zeina Nahleh,MD5;Julie M.Vose,MD5;Julie R.Gralow,MD,FACP,FASCO;Michael Francisco,MPH7;and Shimere Sherwood,PhDD01 https:/doi.org/10.1200/0P.22.00783Accepted March 8,2023ABSTRACTPublished April 7.2023As the voice of cancer care clinicians and the patients they serve,ASCo has taken steps toJCO Oncol Pract 00:1-9elevate awareness about biosimilar products and their use in oncology.In 2018,ASCO released2023 by American Society ofits Statement on Biosimilars in Oncology which was subsequently published in the Journal ofClinical OncologyClinical Oncology to serve as an educational tool which highlighted and provided guidance onseveral topical areas surrounding biosimilars.At the time of its publication,the US Food and▣周▣DrugAdministration(FDA)hadapproved eight biosimilar products for use in the United States,View Onlineincluding one product for use as a supportive care agent in the cancer setting and two productsArticlefor use in the treatment for cancer.This number has risen dramatically (40 approvals),with a■total of 22cancer or cancer-related biosimilar products approved since 2015.Recently,the FDAalso approved the four interchangeable biosimilar products for diabetes,certain inflammatorydiseases,and certain ophthalmic diseases.Given the current market dynamics and the reg-ulatory landscape,this ASCO manuscript now seeks to propose several policy recommenda-tions across the scope of value,interchangeability,clinician barriers,and patient education andaccess.This policy statement is intended to guide ASCO's future activities and strategies andserves to affirm our commitment to providing education to the oncology community on the useof biosimilars in the cancer setting.INTRODUCTIONSeveral factors contributed to the relatively slow adoption ofoncology biosimilars in the US market.These include limitedThe development of biological products in the treatment of understanding of the manufacturing and preapproval pro-cancer care has greatly improved outcomes for patients and cess,limited data on long-term safety and efficacy,concernssurvivors.'-5 However,the increasing use of targeted bio-over potential variations in the product over time,variabilitylogics has driven spending growth.Given the high cost of of substitution practices,lack of clear understanding onbiologics,biosimilars are seen as part of a global strategy to interchangeability,and tactics employed by nonbiosimilarincrease competition,enhance access to care,and reducedrug manufacturers to delay market entry and deter pre-costs.In 2010,the Biologics Price Competition and Inno-scribing of biosimilars.Consequently,biosimilars for thevation Act (BPCIA)was signed into law as part of the Patient treatment of cancer have captured less of the market shareProtection and Affordable Care Act.The BPCIA provided thethan
