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

Abstract

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.

European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia

“…Generic imatinib [61][62][63] is now available worldwide and generic dasatinib is soon to be released. Quality generics have advantages in that the cost of therapy is often significantly reduced, making the drugs more affordable and hence more available to patients with limited resources.…”

Generic formulations of imatinib for treatment of Philadelphia chromosome–positive leukemia in pediatric patients

“…Anecdotal experiences from case reports in adults receiving GI approved outside Canada and the European Union (EU) have described reduced efficacy and safety compared to BI, while two small case series reported equal efficacy of GI and BI (for more details see ). Studies from Canada, India, Iran, and Turkey have demonstrated GI therapy to be well tolerated in patients with CML . Supporting these findings, a single‐center Croatian study showed that equivalent doses of GI and BI result in comparable plasma concentrations and comparable clinical efficacy .…”

“…Studies from Canada, India, Iran, and Turkey have demonstrated GI therapy to be well tolerated in patients with CML. [16][17][18] Supporting these findings, a single-center Croatian study showed that equivalent doses of GI and BI result in comparable plasma concentrations and comparable clinical efficacy. 19 A recently published multicenter retrospective cohort study evaluated efficacy outcomes in 41 adult patients with CML.…”

The Three Year Follow-up of CML Patients Treated with First-line Generic and First-line Branded Imatinib in Bosnia and Herzegovina.

“…Their results showed that MMR rate at 36 months was 93.9% in patients treated with Glivec, compared to 86.5% in patients treated with front-line generic therapy. 13 The same study found that after 18 months, more patients on generic imatinib were switched to nilotinib, compared to patients on Glivec (5.9% vs. 1%, respectively). It is interesting to note that our study showed higher percentage of patients who switched to nilotinib in both studied groups (52% vs. 27%, respectively).…”

“…[6][7][8][9][10] However, studies from Turkey, Canada, India, Bosnia and Herzegovina, and Iran showed that generic therapy is well tolerated in CML patients and that adverse effects are manageable with supportive care. [11][12][13][14][15] In this study, we compared clinical outcomes of patients who received first-line Glivec (Group 1) to patients who received first-line generic imatinib (Group 2) in Bosnia and Herzegovina after three years of therapy. Branded and generic imatinib was administered orally at dosage of 400 mg/day.…”