Prospective single-center study of chronic myeloid leukemia in chronic phase: switching from branded imatinib to a copy drug and back

Alwan, Alaa Fadhil; Matti, Bassam Francis; Naji, Alaadin Sahham; Muhammed, Abdulsalam H; Abdulsahib, Manal Ali

doi:10.3109/10428194.2014.904508

Cited by 20 publications

(21 citation statements)

References 19 publications

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“…The article was first published in February 2014, sharing the accurate and evidencebased data about the efficacy and safety data of generic imatinib in CML available at that time point. 1 Generics of imatinib entered the drug market in Turkey in August 2012, and shortly after the present article 1 was published, our group has published a couple of articles, sharing our-''Cerrahpas¸a'' experience 2-4 regarding this issue, as some other authors 5,6 in 2014.…”

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confidence: 92%

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: 92%

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

Eşkazan

Soysal

2015

J Oncol Pharm Pract

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“…In the literature, some authors suggested that original molecule is superior to generics. 14,15 In a study which was conducted with 30 patients, generic TKI was used as first line therapy and resulted with 90% CHR and 46.7% molecular response rate. 16 On the other hand, a One of the clinical limitation of the reports which suggest generic TKIs are inferior that these studies involve relatively small number of cases or they are just case reports.…”

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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“…Generics of IM have been approved in many countries including Canada, India, Iraq, Colombia and Turkey [3,6,11,12]. The entry of the IM generics into the Turkish drug market has resulted in substantial price reductions since August 2012.…”

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confidence: 99%

“…Alwan et al [11] evaluated the HRs in patients with chronic phase-CML in a prospective study setting where patients had to switch from the original molecule to a generic IM (Imatib, Cipla) for at least 9 months and then switch back to the original IM. Dose escalations to 600 or 800 mg original IM once daily or changing to nilotinib 400 mg twice daily were allowed if patients failed to show optimal response to 400 mg IM after switching from the generic drug.…”

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confidence: 99%

Generics in chronic myeloid leukemia: current arguments for and against and the established evidence

Soysal

Eşkazan

2014

Expert Review of Hematology

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Tyrosine kinase inhibitors became the mainstay of management in patients with chronic myeloid leukemia. The substantially high treatment cost has unfortunately been a major issue. Recent market entry of the imatinib generics are expected to lower the price and increase the availability of the drug worldwide. However, concerns about their efficacy and safety seem to slacken the approval of the generics in many countries. In this editorial, we discuss the current evidence on imatinib generics based mainly on Turkish experience and other limited data available.

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Prospective single-center study of chronic myeloid leukemia in chronic phase: switching from branded imatinib to a copy drug and back

Cited by 20 publications

References 19 publications

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.

Generics in chronic myeloid leukemia: current arguments for and against and the established evidence

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