{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,6]],"date-time":"2025-10-06T09:27:43Z","timestamp":1759742863444},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2021,3,12]],"date-time":"2021-03-12T00:00:00Z","timestamp":1615507200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title \/>\n                  <jats:p>Biosimilars are biologic drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety, and efficacy. Biosimilar epoetin received Food and Drug Administration (FDA) approval in 2018. The manufacturer received an FDA nonapproval letter in 2017, despite receiving a favorable review by FDA's Oncologic Drugs Advisory Committee (ODAC) and an FDA nonapproval letter in 2015 for an earlier formulation. We discuss the 2018 FDA approval, the 2017 FDA ODAC Committee review, and the FDA complete response letters in 2015 and 2017; review concepts of litigation, naming, labeling, substitution, interchangeability, and pharmacovigilance; review European and U.S. oncology experiences with biosimilar epoetin; and review the safety of erythropoiesis-stimulating agents. In 2020, policy statements from AETNA, United Health Care, and Humana indicated that new epoetin oncology starts must be for biosimilar epoetin unless medical need for other epoetins is documented. Empirical studies report that as of 2012, reference epoetin use decreased from 40%\u201360% of all patients with cancer with chemotherapy-induced anemia to &amp;lt;5% of such patients because of safety concerns. Between 2018 and 2020, biosimilar epoetin use varied, increasing to 81% among one private insurer's patients covered by Medicare whose cancer care is administered with Oncology Analytics and to 41% with the same private insurer's patients with cancer covered by commercial health insurance and administered by the private insurer, to 0% in several Veterans Administration Hospitals, increasing to 100% in one large county hospital in California, and with yet-to-be-reported data from most oncology settings. We conclude that biosimilar epoetin appears to have overcome some barriers since 2015, although current uptake in the U.S. is variable. Pricing and safety considerations for all erythropoiesis-stimulating agents are primary determinants of biosimilar epoetin oncology uptake.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Implications for Practice<\/jats:title>\n                  <jats:p>Few oncologists understand substitution and interchangeability of biosimilars with reference drugs. Epoetin biosimilar is new to the market, and physician and patient understanding is limited. The development of epoetin biosimilar is not familiar to oncologists.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1002\/onco.13713","type":"journal-article","created":{"date-parts":[[2021,2,16]],"date-time":"2021-02-16T14:53:58Z","timestamp":1613487238000},"page":"e1418-e1426","source":"Crossref","is-referenced-by-count":2,"title":["The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions"],"prefix":"10.1093","volume":"26","author":[{"given":"Charles L.","family":"Bennett","sequence":"first","affiliation":[{"name":"Toni Stephenson Lymphoma Center, the Hematologic Malignancies Research Institute, the Beckman Research Institute, of the City of Hope Cancer Center, Duarte, California"},{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sumimasa","family":"Nagai","sequence":"additional","affiliation":[{"name":"The University of Tokyo Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew C.","family":"Bennett","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shamia","family":"Hoque","sequence":"additional","affiliation":[{"name":"Department of Civil and Environmental Engineering, College of Engineering and Computing, University of South Carolina, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chadi","family":"Nabhan","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin W.","family":"Schoen","sequence":"additional","affiliation":[{"name":"Saint Louis University School of Medicine, Saint Louis, Missouri"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William J.","family":"Hrushesky","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefano","family":"Luminari","sequence":"additional","affiliation":[{"name":"Hematology, AUSL IRCCS Reggio Emilia"},{"name":"Department CHIMOMO, University of Modena and Reggio Emilia, Regio Emilia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Ray","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul R.","family":"Yarnold","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bart","family":"Witherspoon","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Josh","family":"Riente","sequence":"additional","affiliation":[{"name":"William J Bryan Dorn Veterans Administration Medical Center, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Bobolts","sequence":"additional","affiliation":[{"name":"Oncology Analytics Atlanta, Georgia"},{"name":"College of Pharmacy, Nova Southeastern University, Fort Lauderdale, Florida, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Brusk","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Nova Southeastern University, Fort Lauderdale, Florida, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rebecca","family":"Tombleson","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"},{"name":"College of Pharmacy, Nova Southeastern University, Fort Lauderdale, Florida, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Knopf","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Fishman","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South Carolina"},{"name":"Oncology Analytics Atlanta, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y. Tony","family":"Yang","sequence":"additional","affiliation":[{"name":"George Washington University School of Nursing and Milken Institute School of Public Health, Washington, DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth R.","family":"Carson","sequence":"additional","affiliation":[{"name":"The Division of Hematology\/Oncology, Department of Medicine, Rush University School of Medicine, Chicago, Illinois"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin","family":"Djulbegovic","sequence":"additional","affiliation":[{"name":"The City of Hope, Beckman Research Institute, Department of Computational and Quantitative Medicine, Division of Health Analytics, Evidence-based Medicine & Comparative Effectiveness Research, Duarte, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Restaino","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina, Columbia, South 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