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Poland’s experience with generic imatinib Posted 27/04/2015

In July 2014, Poland became the first country in the European Union (EU) to introduce a generic form of the chronic myeloid leukaemia (CML) treatment imatinib. This, and the dearth of reliable information related to CML patients in Europe who have taken generic imatinib, make the country uniquely positioned to monitor the process of switching from the brand-name drug to its generic, according to author Patrycja Rusicka of the Medical University of Warsaw, Poland [1].

Imatinib blocks the activity of the enzyme tyrosine kinase, which activates specific transcription factors, stimulates myeloid cell proliferation, reduces apoptosis, and alters the cells’ adhesive properties. It was originally launched by Novartis as a treatment for CML under the trade name Glivec (Gleevec in the US).

The European Medicines Agency (EMA) approved the first generic version of imatinib on 18 October 2012 [2] and has since approved three other imatinib generics [3]. In Europe, the basic patent (EP0564409) on Glivec (imatinib) expired in March 2013. The Supplementary Protection Certificate (SPC), however, was expected to protect Glivec in the EU countries against competition from generics until the middle of June 2016 [3].

The only data available for the use of generic imatinib currently comes from developing countries, where other preparations are used, without reliable bioequivalence studies. All generic imatinib drugs registered in Poland have been included in reliable studies.

‘Undoubtedly, it is necessary to appropriately monitor patients with chronic myeloid leukaemia receiving generic drugs in order to ensure their safety and provide information to other countries where therapy based on generic drugs will be introduced in the following years,’ writes Rusicka.

Rusicka has reviewed the current situation with generic imatinib in Poland – the brands authorized (24 different brands, as at 22 May 2014); decisions over reimbursement by the country’s Ministry of Health and National Health Fund; and studies into the drug’s efficacy.

Being the first country in the EU to introduce generic imatinib gives Poland a special obligation to closely monitor the process of switching patients from the originator drug to its generic version. This is not only for the benefit of Polish patients, but also for every country that is either introducing or about to introduce generic imatinib. The process will not be easy, given that several generic drug products will be introduced to the market in Poland at the same time, and patients may receive several different generic brands in quick succession.

Related articles
EMA releases product-specific bioequivalence guidelines

Novartis versus the Indian patent system

Generic imatinib non-inferior to Gleevec

References
1.  Rusicka P. Original vs generic drugs in treatment of chronic myeloid leukaemia. OncoReview.  2014; 4(3):A126-31.
2.   GaBI Online - Generics and Biosimilars Initiative. EMA approves first generic imatinib [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 27]. Available from: www.gabionline.net/Generics/General/EMA-approves-first-generic-imatinib 
3.   GaBI Online - Generics and Biosimilars Initiative. Novartis settles Gleevec lawsuit with Sun Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 27]. Available from: www.gabionline.net/Generics/News/Novartis-settles-Gleevec-lawsuit-with-Sun-Pharma 

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