Original vs generic drugs in treatment of chronic myeloid leukaemia Review article
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Abstract
The beginning of the twenty-first century saw a breakthrough in haematology, oncology and general medicine driven by the introduction of imatinib (Glivec) to the treatment of chronic myeloid leukaemia. For the first time, a neoplastic disease was successfully treated by a therapy targeting the genetic cause of the disease. At present, targeted therapy based on imatinib is the first one to enter a new stage which is the launch of generic drugs. Poland is the first country in the European Union which, from the beginning of July 2014, introduced generic imatinib. Hence, there is no reliable data on its use except for results from bioequivalence tests. The only data available comes from developing countries where other preparations are used, without reliable bioequivalence studies. However, all generic drugs of imatinib registered in Poland have successfully passed such tests. Undoubtedly, it is necessary to appropriately monitor patients with chronic myeloid leukaemia receiving generic drugs in order to ensure their safety and provide information to other countries where therapy based on generic drugs will be introduced in the following years.
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Copyright: © Medical Education sp. z o.o. This is an Open Access article distributed under the terms of the Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). License (https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
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References
2. O’Brien S., Abboud C.N., Akhtari M. et al.: Chronic Myelogenous Leukemia: Clinical Practice Guidelines in Oncology. JNCCN 2012; 10: 64-110.
3. Rowley J.D.: A new consistent chromosomal abnormality in chronic myelogenous leukaemia identified by quinacrine fluorescence and Giemsa staining. Nature 1973; 243: 290-293.
4. Heisterkamp N., Stephenson J.R., Groffen J. et al.: Localization of the c-abl oncogene adjacent to a translocation break point in chronic myelocytic leukemia. Nature 1983; 306: 239-242.
5. Szczylik C., Skorski T., Nicolaides N.C. et al.: Selective Inhibition of Leukemia Cell Proliferation by Bcr-Abl Antisense Oligodeoxynucleotides. Science 1991; 253: 562-5.
6. Stańczak A.: Leki oryginalne czy leki generyczne? (Original or Generic Drugs?) Aptekarz Polski 2011; 63/41.
7. Generic imatinib: review of the literature on clinical efficacy. BC Cancer Agency Care + Research.
8. Experts in Chronic Myeloid Leukemia: The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood 2013; 121: 4439-4442.
9. Ross D.M., Branford S., Seymour J.F. et al.: Safety and efficacy of imatinib cessation for CML patients with stable undetectable minimal residual disease: results from the TWISTER study. Blood 2013; 122(4): 515-522.
10. Razmkhah F., Razavi M., Zaker F. et al.: Hematologic and molecular responses to generic imatinib in patients with chronic myeloid leukemia. Lab. Med. 2009; 41(9): 547-550.
11. Eddou H., Astati S., Mahtat E.M. et al.: The treatment of chronic myeloid leukemia by Imatinib Mesylate generic: About 26 cases. European Hematology Association, London, UK, 9–12 June 2011; Abstract 1234.
12. Nair V., Sharma A., Bhikshapathy M. et al.: Monitoring response to therapy with imatinib mesylate in chronic myeloid leukemia using Indian generic molecule of imatinib. Blood 2008; 112.
13. Alwan A., Adeeb A., Abdulsalam H., Manal A.: Impact of switching therapy from Imatinib Mesylate to generic copy of imatinib on hematological response in patients with chronic phase chronic myeloid leukemia: Single center study. European Hematology Association. London, UK, 9–12 June 2011; Abstract 1215.
14. Mattar M.: Failure of copy Imatinib (CIPLA, India) to maintain hematologic and cytogenetic responses in chronic myeloid leukemia in chronic phase. Int. J. Hematol. 2010; 91(1): 104-106.
15. Goubran H.A.: 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 Rep. 2009; 3: 7112.
16. Asfour I.A., Elshazly S.A.: 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.
17. 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(2): 272-276.
18. O’ Brien S.G., Guilhot F., Larson R.A.: Imatinib compared with interferon and low-dose cytarabine for newly diagnosed CP-CML. N. Engl. J. Med. 2003; 348(11): 994-1004.
19. Saglio G., Kim D.W., Issaragrisil S. et al.: Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N. Engl. J. Med. 2010; 362(24): 2251-2259.
20. Larson R.A, Hochhaus A., Hughes T.P. et al.: Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia 2012; 26(10): 2197-2203.
21. Anstrom K.J., Reed S.D., Glendenning G.A. et al.: Estimated long-term survival benefit of imatinib therapy in patients with newly diagnosed chronic myeloid leukemia. Am. Soc. Clin. Oncol. 2003; 101(11): 2574-2583.
22. Moshfeghi K., Nazemzadeh N., Mehrzad V. et al.: Comparison of effectiveness and safety of Iranian-made vs. Indian-made imatinib in treatment of chronic myeloid leukemia. Adv. Biomed. Res. 2013; 2: 17.