{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T23:50:21Z","timestamp":1773705021151,"version":"3.50.1"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,6,26]],"date-time":"2021-06-26T00:00:00Z","timestamp":1624665600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,6,26]],"date-time":"2021-06-26T00:00:00Z","timestamp":1624665600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Viatris, Inc"},{"DOI":"10.13039\/100007777","name":"Biocon","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007777","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Endocr Disord"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>MYL-1501D is a proposed biosimilar to insulin glargine. The noninferiority of MYL-1501D was demonstrated in patients with type 1 diabetes and type 2 diabetes in 2 phase 3 trials. Immunogenicity of MYL-1501D and reference insulin glargine was examined in both studies.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>INSTRIDE 1 and INSTRIDE 2 were multicenter, open-label, randomized, parallel-group studies. In INSTRIDE 1, patients with type 1 diabetes received MYL-1501D or insulin glargine over a 52-week period. In INSTRIDE 2, patients with type 2 diabetes treated with oral antidiabetic drugs, insulin naive or not, received MYL-1501D or reference insulin glargine over a 24-week period. Incidence rates and change from baseline in relative levels of antidrug antibodies (ADA) and anti\u2013host cell protein (anti-HCP) antibodies in both treatment groups were determined by a radioimmunoprecipitation assay and a bridging immunoassay, respectively. Results were analyzed using a mixed-effects model (INSTRIDE 1) or a nonparametric Wilcoxon rank sum test (INSTRIDE 2).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Total enrollment was 558 patients in INSTRIDE 1 and 560 patients in INSTRIDE 2. The incidence of total and cross-reactive ADA was comparable between treatment groups in INSTRIDE 1 and INSTRIDE 2 (<jats:italic>P<\/jats:italic>\u2009&gt;\u20090.05 for both). A similar proportion of patients had anti-HCP antibodies in both treatment groups in INSTRIDE 1 at week 52 (MYL-1501D, 93.9\u2009%; reference insulin glargine, 89.6\u2009%; <jats:italic>P<\/jats:italic>\u2009=\u20090.213) and in INSTRIDE 2 at week 24 (MYL-1501D, 87.3\u2009%; reference insulin glargine, 86.9\u2009%; <jats:italic>P<\/jats:italic>\u2009&gt;\u20090.999).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>In INSTRIDE 1 and INSTRIDE 2, similar immunogenicity profiles were observed for MYL-1501D and reference insulin glargine in patients with type 1 diabetes and type 2 diabetes, respectively.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov, INSTRIDE 1 (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02227862\">NCT02227862<\/jats:ext-link>; date of registration, August 28, 2014); INSTRIDE 2 (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02227875\">NCT02227875<\/jats:ext-link>; date of registration, August 28, 2014).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12902-021-00797-4","type":"journal-article","created":{"date-parts":[[2021,6,26]],"date-time":"2021-06-26T10:03:11Z","timestamp":1624701791000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies"],"prefix":"10.1186","volume":"21","author":[{"given":"Bin","family":"Sun","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nilanjan","family":"Sengupta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anita","family":"Rao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles","family":"Donnelly","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vinit","family":"Waichale","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arnab Sinha","family":"Roy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shilpa","family":"Ramaswamy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Divya","family":"Pathak","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald R.","family":"Bowsher","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yaron","family":"Raiter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick","family":"Aubonnet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abhijit","family":"Barve","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,6,26]]},"reference":[{"issue":"Suppl 1","key":"797_CR1","first-page":"S11-24","volume":"40","author":"American Diabetes Association","year":"2017","unstructured":"American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2017;40 Suppl 1:S11-24.","journal-title":"Diabetes Care"},{"key":"797_CR2","doi-asserted-by":"publisher","first-page":"847","DOI":"10.1016\/S0140-6736(06)68341-4","volume":"367","author":"D Daneman","year":"2006","unstructured":"Daneman D. Type 1 diabetes. Lancet. 2006;367:847\u201358.","journal-title":"Lancet"},{"key":"797_CR3","doi-asserted-by":"crossref","unstructured":"Inzucchi SE, Sherwin RS. Type 2 diabetes mellitus. In: Goldman L, Shafer A, editors. Goldman\u2019s Cecil medicine. 24th ed. Philadelphia: Elsevier; 2011. p. e78\u201394.","DOI":"10.1016\/B978-1-4377-1604-7.00561-3"},{"issue":"Suppl 1","key":"797_CR4","first-page":"S48-56","volume":"40","author":"American Diabetes Association","year":"2017","unstructured":"American Diabetes Association. Glycemic targets. 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The protocols were reviewed and approved by independent ethics committees\/institutional review boards in accordance with local legal regulations. All patients provided written informed consent before enrollment in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"BS, CD, YR, PA, and AB are paid employees of Viatris Inc and may hold stock or stock options in the company. NS, AR, and SR are paid employees of Biocon Research Limited and may hold stock or stock options in the company. VW, ASR, and DP were employees of Biocon Research Limited during the time of the study and may hold stock or stock options in the company. RRB has served as a consultant for Viatris Inc.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"129"}}