{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,26]],"date-time":"2026-01-26T12:48:36Z","timestamp":1769431716875,"version":"3.49.0"},"reference-count":40,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"2","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Oncol Pract"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>Although multiple filgrastim biosimilars are now available in the United States, no studies comparing clinical outcomes between products have been reported. This analysis evaluated real-world outcomes of filgrastim-aafi and filgrastim-sndz in patients with select solid tumors receiving myelosuppressive chemotherapy to compare the two filgrastim biosimilars.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS<\/jats:title>\n            <jats:p>This was an observational, noninferiority, cohort study of patients from three integrated health care systems who received myelosuppressive chemotherapy and were prophylactically initiated on filgrastim-sndz between January and November 2021 or filgrastim-aafi between June and November 2022. Patients were followed from filgrastim biosimilar initiation until the start of their next chemotherapy cycle. The primary outcome of severe neutropenia was analyzed using a binary noninferiority test with a 5% upper margin. Secondary outcomes included the incidence of emergency department or hospital encounters due to febrile neutropenia and systemic antibiotic\/antifungal medication use. If noninferiority was met, adjusted logistic regression modeling was conducted.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>\n              A total of 2,730 patients who initiated filgrastim-aafi (n = 880) or filgrastim-sndz (n = 1,850) during the study period were included. The overall mean age was 55 years, 87.4% were female, 42.3% were White, and 76.6% had breast cancer. Severe neutropenia occurred in 1.8% and 1.7% of patients initiated on filgrastim-aafi and filgrastim-sndz, respectively (\n              <jats:italic>P<\/jats:italic>\n              &lt; .01 for noninferiority). The adjusted odds ratio for severe neutropenia with filgrastim-aafi compared with filgrastim-sndz was 0.91 (95% CI, 0.49 to 1.68;\n              <jats:italic>P<\/jats:italic>\n              = .76). Noninferiority was met for all secondary outcomes (\n              <jats:italic>P<\/jats:italic>\n              &lt; .01), and there were no adjusted statistically significant differences between the groups (all\n              <jats:italic>P<\/jats:italic>\n              &gt; .05).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>Among patients with select solid tumors receiving myelosuppressive chemotherapy, severe neutropenia outcomes were comparable between filgrastim-aafi and filgrastim-sndz biosimilars. Findings from this study may support utilization of different filgrastim biosimilars in clinical practice.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/op.24.00047","type":"journal-article","created":{"date-parts":[[2024,7,24]],"date-time":"2024-07-24T19:59:28Z","timestamp":1721851168000},"page":"245-251","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":2,"title":["Real-World Noninferiority Assessment of Two Filgrastim Biosimilars in Patients Receiving Myelosuppressive Chemotherapy"],"prefix":"10.1200","volume":"21","author":[{"given":"Ye Ji","family":"Lee","sequence":"first","affiliation":[{"name":"Oncology Pharmacy, Antelope Valley Medical Offices, Kaiser Permanente, Lancaster, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6530-8415","authenticated-orcid":true,"given":"Thomas","family":"Delate","sequence":"additional","affiliation":[{"name":"Pharmacy Outcomes Research Group, Kaiser Permanente National Pharmacy, Aurora, CO"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0014-2431","authenticated-orcid":true,"given":"Rita L.","family":"Hui","sequence":"additional","affiliation":[{"name":"Pharmacy Outcomes Research Group, Kaiser Permanente National Pharmacy, Oakland, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim","family":"Le","sequence":"additional","affiliation":[{"name":"Pharmacy Outcomes Research Group, Kaiser Permanente National Pharmacy, Downey, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-8156-374X","authenticated-orcid":true,"given":"Catherine","family":"Pham","sequence":"additional","affiliation":[{"name":"Pharmacy Outcomes Research Group, Kaiser Permanente National Pharmacy, Downey, CA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.62.3488"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2010.10.013"},{"key":"e_1_3_6_4_2","unstructured":"US Food and Drug Administration: Biosimilar product information. https:\/\/www.fda.gov\/drugs\/biosimilars\/biosimilar-product-information"},{"key":"e_1_3_6_5_2","unstructured":"Jeremias S: FDA approves third filgrastim biosimilar: Releuko. https:\/\/www.ajmc.com\/view\/fda-approves-third-filgrastim-biosimilar-releuko"},{"key":"e_1_3_6_6_2","doi-asserted-by":"publisher","DOI":"10.1200\/OP.22.00639"},{"key":"e_1_3_6_7_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2021.2634"},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.44670"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.1200\/OP.22.00783"},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-023-00593-7"},{"key":"e_1_3_6_11_2","first-page":"2159","article-title":"Healthcare system conversion to a biosimilar: Trials and tribulations","volume":"78","author":"Lam SW","year":"2021","unstructured":"Lam SW, Amoline K, Marcum C, et al: Healthcare system conversion to a biosimilar: Trials and tribulations. 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