Efficacy and safety of generic imatinib after switching

Genéricos/Investigación | Posted 15/02/2018 post-comment0 Post your comment

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

Cancer Cell V13I20

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].

Related article
Persistence with generic imatinib in CML patients

EMA approves first generic imatinib

References
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010