References
- Glivec (imatinib mesylate) [prescribing information]. Basel, Switzerland: Novartis Pharma AG; 2008.
- Deininger M, O’Brien SG, Guilhot F, et al. International randomized study of interferon vs STI571 (IRIS) 8-year follow up: sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) treated with imatinib. Blood 2009;114(Suppl. 1): Abstract 1126.
- Kefalas CH, Ciociola AA. The FDA's generic-drug approval process: similarities to and differences from brand-name drugs. Am J Gastroenterol 2011;106:1018–1021.
- US Food and Drug Administration/Center for Drug Evaluation and Research, Office of Generic Drugs. Abbreviated New Drug Application (ANDA): Generics. 2010; 2011. Available from: www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/default.htm
- Chouffai Z. Hematologic relapse after 2 years on a non-authorized copy version of imatinib in a patient with chronic myeloid leukemia in chronic phase: a case report. Case Rep Oncol 2010;3:272–276.
- Asfour IA, Elshazly SA. Changing therapy from Glivec to a “copy” imatinib results in a worsening of chronic myeloid leukemia disease status: two case reports. Cases J 2009;2:9342.
- Mattar M. Failure of copy Imatib (CIPLA, India) to maintain hematologic and cytogenetic responses in chronic myeloid leukemia in chronic phase. Int J Hematol 2010;91:104–106.
- Goubran HA. Failure of a non-authorized copy product to maintain response achieved with imatinib in a patient with chronic phase chronic myeloid leukemia: a case report. J Med Case Reports 2009;3:1–3.
- Baccarani M, Cortes J, Pane F, et al. Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol 2009;27:6041–6051.
- Giles FJ, O’Dwyer M, Swords R. Class effects of tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia. Leukemia 2009;23:1698–1707.