{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T22:37:02Z","timestamp":1777934222688,"version":"3.51.4"},"reference-count":29,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2014,2,21]],"date-time":"2014-02-21T00:00:00Z","timestamp":1392940800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"published-print":{"date-parts":[[2015,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Generic imatinib has recently been approved for chronic myeloid leukemia in Canada and the European Union (EU). There are anecdotal concerns of reduced efficacy related to generic vs. brand name imatinib.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>MEDLINE and EMBASE were searched. Generic imatinib product monographs approved by Health Canada and the European Medicines Agency (EMA) were reviewed. Medical information of Novartis, Teva and Apotex were contacted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Several issues have been raised. First, generic imatinib approved outside Canada and the European Union has been associated with reduced efficacy in small case reports and contradictory findings with two case series. However, the clinical bioequivalence of these generic products has not been clearly established. Secondly, use of generic imatinib in other populations has been questioned. However, imatinib absorption is not significantly different in pediatric chronic myeloid leukemia or patients with gastrointestinal tumours compared to adults with chronic myeloid leukemia. Although reduced absorption was reported after gastric bypass and gastrectomy, imatinib absorption occurs mostly in the ileum, duodenum, colon and jejunum. Change in gastric acidity has also been shown to not affecting imatinib absorption. Finally, beta-crystal form of brand name imatinib is more stable than the alpha-crystal form of generic imatinib at room temperature. However, the EMA found both crystal forms to be highly soluble and polymorphism would not significantly influence the performance of generic imatinib.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Overall, anecdotal concerns appear to be unfounded for generic imatinib approved in Canada and the EU. There is no evidence that these generic imatinib products are less effective than brand name imatinib.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1078155214522143","type":"journal-article","created":{"date-parts":[[2014,2,22]],"date-time":"2014-02-22T00:07:21Z","timestamp":1393027641000},"page":"76-79","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":20,"title":["Clinical efficacy of generic imatinib"],"prefix":"10.1177","volume":"21","author":[{"given":"Mario L","family":"de Lemos","sequence":"first","affiliation":[{"name":"BC Cancer Agency, Vancouver, BC, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victoria","family":"Kyritsis","sequence":"additional","affiliation":[{"name":"BC Cancer Agency, Vancouver, BC, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2014,2,21]]},"reference":[{"key":"bibr1-1078155214522143","unstructured":"Teva Canada Ltd. TEVA-IMATINIB\u00ae product monograph. ON, Canada, 28 March 2013."},{"key":"bibr2-1078155214522143","unstructured":"Apotex Inc. APO-IMATINIB\u00ae product monograph. Toronto, ON, Canada, 4 June 2013."},{"key":"bibr3-1078155214522143","unstructured":"European Medicines Agency. Assessment Report\u2009-\u2009Imatinib Teva. London, UK, 18 October 2012."},{"key":"bibr4-1078155214522143","unstructured":"European Medicines Agency. Assessment Report\u2009-\u2009Imatinib Actavis. London, UK, 21 February 2013."},{"key":"bibr5-1078155214522143","unstructured":"European Medicines Agency. Assessment Report\u2009-\u2009Imatinib Accord. 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Presented at:\n                      The Congress of the European hematology association\n                      , London, UK, 11 June 2011, abstract 1219."},{"key":"bibr12-1078155214522143","unstructured":"Chronic Myelogenous Leukemia Society of Canada. Generic tyrosine kinase inhibitors (TKIs) arrive in Canada. Chronic Myelogenous Leukemia Society of Canada, Undated, http:\/\/cmlsociety.org\/generic-tyrosine-kinase-inhibitors-tkis-arrive-in-canada\/ (accessed 6 January 2014)."},{"key":"bibr13-1078155214522143","unstructured":"GIS\u2009-\u2009GIST Support International. Generic Gleevec. GIS\u2009-\u2009GIST Support International, 20 December 2013, http:\/\/gistsupport.medshelf.org\/Generic_Gleevec (accessed 6 January 2014)."},{"key":"bibr14-1078155214522143","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2009.10.009"},{"key":"bibr15-1078155214522143","doi-asserted-by":"publisher","DOI":"10.4172\/jbb.1000077"},{"key":"bibr16-1078155214522143","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-010-0718-2"},{"key":"bibr17-1078155214522143","unstructured":"Cipla. IMATIB\u00ae product monograph. Mumbai, India, July 2012."},{"key":"bibr18-1078155214522143","unstructured":"Novartis Pharmaceuticals Canada Inc. GLEEVEC\u00ae product monograph. 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