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Efficacy and safety of generic imatinib after switching Posted 15/02/2018

A study carried out by researchers from the US investigated switching from originator to generic imatinib in patients treated for chronic myeloid leukaemia [1].

In February 2016, a generic formulation of imatinib was introduced in the US [2] and many patients have migrated to this formulation at the request of their insurance provider in order to reduce costs. However, since the approval of generics does not generally require comparative studies, physicians and patients are sometimes concerned about whether switching from originator to generic drugs may affect efficacy and/or safety. To address this concern, the authors analysed the outcome of patients switched from originator to generic imatinib for changes in efficacy or adverse event profile.

The records of patients diagnosed with chronic myeloid leukaemia (CML) and treated with originator imatinib and subsequently switched to generic imatinib between 2000 and 2017 were reviewed.

Of the 24 patients that switched to generic imatinib all maintained the same level of cytogenetic and molecular response they had before the switch. Although some new adverse events were reported after switching, the authors concluded that the ‘change appears to be generally safe’. They added, however, that ‘more patients and longer follow-up is required to confirm these observations’.

These data were presented at the American Society of Hematology’s (ASH) 59th Annual Meeting and Exposition, which was held on 9−12 December 2017 in Atlanta, GA, USA.

Conflict of interest
The authors of the abstract [1] have received research funding from various pharmaceutical companies. For full details of the authors’ conflict of interest, see the abstract [1].

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1. Aboudalle I, Hagop M. Kantarjian, Jan A. Burger, Zeev Estrov, Maro Ohanian, Elias J. et al. Efficacy and safety of generic imatinib after switching from innovator imatinib in patients treated for chronic myeloid leukemia. Blood. 2017;130:2906.
2. GaBI Online - Generics and Biosimilars Initiative. Sun Pharma launches imatinib mesylate in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 15]. Available from: www.gabionline.net/Generics/News/Sun-Pharma-launches-imatinib-mesylate-in-the-US

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