Clinical efficacy of generic imatinib

Lemos, Mário L de; Kyritsis, Victoria

doi:10.1177/1078155214522143

Cited by 23 publications

(25 citation statements)

References 15 publications

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“…Studies have shown no difference in water solubility, and absorption between generic and branded imatinib. 17 Three forms of imatinib are identified (α-, β-and γ-crystalline forms), of which the β polymorph is more thermodynamically stable. 18 The branded imatinib is in the β-crystal form, while the majority of generics have the α-form.…”

Section: Discussionmentioning

confidence: 99%

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

Islamagić¹

2017

UHOD

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Imatinib mesylate, a selective BCR-ABL tyrosine kinase inhibitor, has been well established as the standard of care for chronic myeloid leukaemia patients. In this study, we compared clinical outcomes of patients who received first-line Glivec (Group 1) with patients who received first-line generic imatinib (Group 2) in Bosnia and Herzegovina with three years follow-up of therapy. At 24 months of therapy, the achievement of complete cytogenetic response and major molecular response were comparable between the studied groups (CCyR was 69% vs. 70%, respectively; MMR was 54% vs. 48%, respectively). After comparing the reasons for the switch to nilotinib, we found that treatment failure was higher in patients treated with generic imatinib (30% vs. 8%, respectively) and side effects were similar in both patient groups (22% vs. 19%, respectively). In general, patients on first-line generic imatinib had higher rates of treatment failure compared to patients treated with first-line branded imatinib. Keywords: Generic imatinib, Glivec, Clinical outcomes, CML ÖZET Bosna Hersek'te İlk-basamak Jenerik ve İlk-basamak Preparat Imatinib ile Tedavi Edilmiş CML Hastalarının Üç Yıllık TakbiSelektif BCR-ABL tirozin kinaz inhibitörü olan İmatinib Mesilat, Kronik miyeloid lösemi hastalarının tedavisinde iyi bir standart olarak saptanmıştır. Bu çalışmada, Bosna Hersek'teki İlk-basamak Glivec (Grup 1) alan hastalarla ilk-basamak jenerik imatinib (Grup 2) alan hastaların klinik sonuçlarını üç yıllık tedavi takibi ile karşılaştırdık. 24 aylık tedavide, tam sitogenetik cevap ve majör moleküler cevabın başarısı, incelenen gruplar arasında karşılaştırılabilir düzeydeydi (sırasıyla, CCyR %69'a karşı %70; MMR, sırasıyla %54'e karşı %48 idi).Nilotinib'e geçiş nedenlerini karşılaştırdıktan sonra, jenerik imatinib ile tedavi edilen hastalarda tedavi başarısızlığının daha yüksek olmakla beraber (sırasıyla %30 ve %8), yan etkiler her iki hasta grubunda benzerdi (sırasıyla, %22'ye karşı %19). Genel olarak, ilk-basamak jenerik imatinib verilen hastalarda başarısızlık oranlarını, ilk-basamak preparat imatinib ile tedavi edilen hastalara kıyasla daha yüksek saptadık.

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Section: Discussionmentioning

confidence: 99%

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

Islamagić¹

2017

UHOD

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“…Some case reports/series [2][3][4][5][6] raised concerns about its efficacy but refer to generics with questionable bioequivalence. 7 To date, there is no evidence that imatinib generics approved in North America and the European Union (EU) lack efficacy compared to the branded drug, even when comparing different imatinib crystal forms. 7 Several studies correlated imatinib plasma concentrations (IPC) with adequate treatment response.…”

Section: Introductionmentioning

confidence: 99%

“…7 To date, there is no evidence that imatinib generics approved in North America and the European Union (EU) lack efficacy compared to the branded drug, even when comparing different imatinib crystal forms. 7 Several studies correlated imatinib plasma concentrations (IPC) with adequate treatment response. [8][9][10] Recommended therapeutic imatinib plasma concentration (IPC) is between 1000 µmol/L and 3000 µmol/L.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Branded and Generic Imatinib Plasma Concentrations in Patients With Chronic Myelogenous Leukemia: Unicentric Study

Ostojić

Sertić

Rončević

et al. 2016

Clinical Lymphoma Myeloma and Leukemia

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“…For example in Canada and Europe generic IM has been approved for CML recently. 2 However in Turkey, generic IM preparations are currently present. In Turkey, between original and generic molecules of TKI's there is a price difference because of the reimbursement policy.…”

Section: Introductionmentioning

confidence: 99%

“…The major concern for generic IM is its efficacy over the original drug, Glivec or Gleevec, although actually generics were shown to be bioequivalent in many basic studies. 2 Elucidation of the non-inferiority of generic imatinib over the original molecule is important for effective clinical decision making in CML. 3 The aim of this multi-center study is to assess the efficacy of generic IM over Glivec in terms of hematological, cytogenetic, and molecular responses in CML.…”

Section: Introductionmentioning

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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Clinical efficacy of generic imatinib

Abstract: 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.

Cited by 23 publications

References 15 publications

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

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

Comparison of Branded and Generic Imatinib Plasma Concentrations in Patients With Chronic Myelogenous Leukemia: Unicentric Study

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

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