Response to the case report by Mattar: Generic Imatinib (Imatib, Cipla) in a patient with chronic myeloid leukemia in chronic phase

Gogtay, Jaideep; Chahchad, Siddharth; Jadhav, Sonali; Purandare, Shrinivas

doi:10.1007/s12185-010-0718-2

Cited by 9 publications

(6 citation statements)

References 1 publication

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“…8 As de Lemos and Kyritsis 1 had mentioned, in the current literature, there are some case reports showing the efficacy and safety of generics of imatinib with contradictory results. [9][10][11] Since there are various generics available in different countries, 4 and keeping in mind that all generics are not the same, making a generalization based on the evidence obtained from one generic molecule is not always justified, as generics may vary in their formulation and production quality, leading to potential differences in their efficacy and safety. 12 However, as the authors stated, generics have been shown to be bioequivalent to the original imatinib (Gleevec or Glivec), with similar serum imatinib levels, 1,13 leading to the impression that their pharmacological effect would be similar to that of the original molecule.…”

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confidence: 99%

Generic imatinib in the treatment of chronic myeloid leukemia: Cerrahpaşa experience

Eşkazan

Soysal

2015

J Oncol Pharm Pract

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As the first tyrosine kinase inhibitor (TKI), imatinib (Gleevec or Glivec, Novartis Pharmaceuticals) was introduced, the treatment of chronic myeloid leukemia (CML) has changed radically, and the TKIs are now the mainstay of CML treatment. The substantially high treatment cost has unfortunately been a major issue, which puts a strain on health-care budgets even in developed countries. So reimbursement policies encourage generic drug (i.e. generic imatinib) use to lower the expenses, and it is true that generics would lead to considerable cost savings, but they also give rise to questions associated with their efficacy, safety and quality. In this commentary, we discuss the current evidence on generic imatinib based mainly on our "Cerrahpaşa" experience along with other data available in the literature together with the data discussed by de Lemos and colleagues.

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confidence: 99%

Generic imatinib in the treatment of chronic myeloid leukemia: Cerrahpaşa experience

Eşkazan

Soysal

2015

J Oncol Pharm Pract

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“…18,19,20 Furthermore it is also unclear whether the generic IM which was used in these studies was bioequivalent or not. 21 Likewise, there are speculations about the different crystal forms of IM may affect its clinical efficacy. However in literature there are no reports of different clinical efficacy related to polymorphism of IM.…”

Section: Discussionmentioning

confidence: 99%

Generic Imatinib Mesylate is as Effective as Original Glivec in the Clinical Management of CML.

Malkan¹

2015

UHOD

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Unsustainable drug prices in chronic myeloid leukemia (CML) and cancer may be causing harm to patients. The aim of this multicenter study is to assess the efficacy of generic imatinib mesylate (IM) over Glivec in terms of hematological, cytogenetic, and molecular responses in CML. The data of 120 CML patients, who were treated with generic or original form of IM, were obtained from six different hematology clinics in Turkey between the years of 2009-2014 and analyzed retrospectively. Initial evaluation revealed that only one patient who was using original molecule switched to second generation tyrosine kinase inhibitor (TKI). In this period, hematological response(HR) was observed in 99.2% of the patients, cytogenetic response (CR) was observed in 88.7% of the patients (47 of 53), and molecular response (MR) was observed in 75% of the patients. Clinicians had a tendency to prefer generic molecules in each sequent visit, and this switch rate was statistically significant (p< 0.001). 11 patients, who were using original molecules during all cohorts, switched to second generation TKI. On the other hand, only one patient, who was using generic molecules, switched to second generation TKI. Our paper may help to clarify the doubts about the efficacy of generic IM compared to original molecule. In our study we did not find any significant difference in HR, CR, and MR for original and generic drugs in each visit. Herein, we find low rates of need to switch to second generation TKIs with generic IM and no difference in treatment responses between generic and original molecules that confirms the non-inferiority of generic TKIs over original molecules.

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“…[23][24][25][26] By contrast, recent reports show that the efficacy and tolerability of generics were comparable with those of Glivec after switching. [27][28][29] In the former reports, [23][24][25][26] the measurement of plasma concentration of imatinib was not performed at before and after changing to generic drugs. Accumulating evidence indicates that trough imatinib plasma level is correlated to response in the treatment of patients with CML.…”

Section: Discussionmentioning

confidence: 99%

Comparative Study of the Anti-leukemic Effects of Imatinib Mesylate, Glivec™ Tablet and Its Generic Formulation, OHK9511

Yokoo

Kubota

Tabe

et al. 2015

Biological & Pharmaceutical Bulletin

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Long-term treatment with imatinib mesylate (IM) allows patients with chronic myeloid leukemia (CML) to live a near-normal lifespan. However, the fact that tyrosine kinase inhibitors, including IM, are extremely expensive is a major cause of poor adherence, resulting in disease relapse or drug resistance. Therefore, physicians are encouraged to prescribe generic drugs to reduce the financial burden of medical expenses. In Japan, only generic drugs that have a basic chemical structure and pharmacokinetic data that are the same as those of the original drug are approved. However, it is not mandatory to demonstrate that generic drugs have adequate biological effects. This is one of the reasons why Japanese hematologists do not often use generic IM. The aim of the present study was to compare the anti-leukemic effects of Glivec (a commercial IM) and its generic formulation, OHK9511. The IC 50 values of OHK9511 and Glivec were comparable, and both induced similar levels of apoptosis in several CML cell lines. Furthermore, the overall survival of OHK9511-treated mice transplanted with BCR-ABL-positive cells was similar to that of mice treated with Glivec . Although the experiments performed herein were basic, the results suggest that physicians should consider using generic IM.

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Response to the case report by Mattar: Generic Imatinib (Imatib, Cipla) in a patient with chronic myeloid leukemia in chronic phase

Cited by 9 publications

References 1 publication

Generic imatinib in the treatment of chronic myeloid leukemia: Cerrahpaşa experience

Generic imatinib in the treatment of chronic myeloid leukemia: Cerrahpaşa experience

Generic Imatinib Mesylate is as Effective as Original Glivec in the Clinical Management of CML.

Comparative Study of the Anti-leukemic Effects of Imatinib Mesylate, Glivec™ Tablet and Its Generic Formulation, OHK9511

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