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New generic versions of imatinib mesylate join the US market Posted 26/08/2016

Two new generic versions of Novartis’ imatinib mesylate (marketed as Gleevec® and Glivec®) were launched in the US in early August 2016.

Imatinib mesylate is a tyrosine kinase inhibitor (TKI), a type of drug used in the treatment of certain forms of cancer [1]. This particular TKI has had notable use in patients with chronic myeloid leukaemia, Philadelphia chromosome positive chronic myeloid leukaemia and gastrointestinal stromal tumours [2]. Novartis’ patent for this drug recently expired in the US, which has left them vulnerable to generics competition. Apotex and Teva join other pharmaceutical companies, such as Sun Pharma, in bringing generic forms of the drug to the market [3]. A similar movement is also being observed in Europe.

According to US IMS data for the year ending May 2016, Gleevec sales were in excess of US$2.4 billon. Apotex and Teva are generics companies with headquarters in Canada and Israel, respectively. They both launch their US Food and Drug Administration approved products in 100 mg and 400 mg tablets and aim to tap into Novartis’ originator product sales [2]. Estimates of possible US patient savings cannot be made at this time, but pricings of imatinib generics in Turkey can lead to savings of US$130 per box [4].

Apotex is launching an ‘Imatinib Instant Savings Card’ that aims to increase product availability to patients. Details of how this scheme will work have not yet been released, but will be available via this website, www.ImatinibZeroCopay.com, in due course. However, this is not the first or only such programme available. Sun Pharma launched the ‘Sun Pharma Imatinib Mesylate Savings Card’ in early 2016. This is a co-payment card for privately insured patients providing them with greater access to the drug and reducing out-of-pocket expenses that may exceed an affordable amount. The programmes initially appear similar in their aims that are to deliver greater access to the drug for patients, through increasing affordability.

Jeff Watson, President of Global Generics at Apotex, issued the following statement following the product launch, ‘We are very excited to make a more affordable version of this important cancer medication available to the US market. It demonstrates our continued dedication to provide high quality, cost saving generic products to the US healthcare system’.

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References
1. Eckstein E, et al. Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(2):79-87. doi:10.5639/gabij.2014.0302.021
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 2016 August 26]. Available from:
 www.gabionline.net/Generics/News/Sun-Pharma-launches-imatinib-mesylate-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. The satisfaction of healthcare payers, patients and physicians with generic imatinib [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 August 26]. Available from: www.gabionline.net/Generics/Research/The-satisfaction-of-healthcare-payers-patients-and-physicians-with-generic-imatinib
4. GaBI Online - Generics and Biosimilars Initiative. Generic imatinib non-inferior to Gleevec [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 August 26]. Available from:
 www.gabionline.net/Generics/Research/Generic-imatinib-non-inferior-to-Gleevec

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Source: Apotex, EMA, Teva

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