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Generic imatinib-risks and issues

It will be of interest to all of us as CML patients currently taking the branded version of imatinib namely Glivec that not so far into the future that it will be off patent and that generic imatinib will be offered in UK by we presume by a range of manufacturers and be available for import from existing manufacturers of the medication.
I remember seeing a blog in the past that Health Canada was offering and /or funding only generic imatinib and that patients were unhappy and some described it unreliable and additionally the side effects from the new formulation were extremely troublesome.The full story may be updated by exploring the website of CML Society of Canada -cmlsociety.org.
Some patient activists have taken to flooding government deparments in Canada with spam to make their point that generic imatinib is harmful to patients.Currently the CML Society of Canada is instituting a patient survey, of those previously on branded imatinib but now on the generic version,in order then to present to government their findings and be able to influence future health policies.
Another useful source is offered by CMLAdvocates.net where on their website one may access the CMLHorizons conference 2014 held in Serbia where there were a number of presentations on the topic of imatinib generics and copy drugs.
I am not an expert in pharmacokinetics so will not attempt to summarise but suggest that you may wish to consider these two sources.Has anyone else come across the issues surrounding generic imatinib?Basically patients are concerned that they may lose any progression in their PCR score and be subject to previously unknown and uncomfortable side effects.
Perhaps we need to inform and prepare ourselves to deal with similar issues to those which have arisen in Canada?
Best wishes
John

Hi John,

I will be asking the CML clinicians who are attending the UK CML patient/carer day in Newcastle about this issue this coming Saturday.

Thanks for bringing the subject to our attention as we will have to address it soon.

Meanwhile I have uploaded a PDF of the EMA Summary for the generic: 'Imatinib Teva' on the home page.

This press release is also interesting:

Novartis Pharmaceuticals Corporation has settled its litigation with a subsidiary of Sun Pharmaceutical Industries Ltd. relating to Novartis patents covering the use of certain polymorphic forms of Gleevec® (imatinib mesylate), which expire in 2019 (including pediatric exclusivity). The basic compound patent for Gleevec expires in the U.S. on July 4, 2015.

As a result of the settlement, Novartis will permit Sun Pharma's subsidiary to market a generic version of Gleevec in the United States on February 1, 2016. The terms of the settlement agreement are otherwise confidential. Sun Pharma's subsidiary has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of imatinib mesylate. that Novartis have settled with Sun Pharma

http://www.novartis.com/newsroom/media-releases/en/2014/1785478.shtml

Sandy

Hi john,

I'm brazilian and here the public service uses generic imatinib. my doctor said that he believes that the medication is good, but there's not study about it. i've heard about a few cases of failure in the generics, but most of people i know do well on generic imatinib. My doctor also told me that it's not that complex to make a generic imatinib, but he prefers to use the brand one. i had the generic imatinib for 2 months and the brand one for 6 months and did not notice any side effect. i'm now on tasigna.

Hi John

Personally, I have no concern about using a generic that has been approved by the FDA or EMA. They have to be bioequivalent, which means they achieve the same levels of active in the body as the reference product (Glivec). And excipients have to be pharmaceutically acceptable - essentially, on an approved list. It's pretty rare that excipients make any difference at all, and even then it tends to be very minor. And I can't see they would be the cause of side effects. If they were, Novartis would have changed them by now for better ones in Glivec itself.

The switch to generics is never as straightforward as it perhaps ought to be. The reference drug maker will want to try to keep as many patients on their drug as they can (which is why switching to new generation drugs like nilotinib is a very well trodden path - in the case of nilotinib, however, it is generally regarded as "better" - certainly for patients who may not do so well on imatinib - so in this case the second generation does have real benefit for patients).

So it's common with many drugs when the switch to generics comes for there to be comment that somehow generics are less good. This is very rarely the case. Of course with a condition like CML, patients are naturally nervous but I would be very cautious personally about anecdotal suggestions of a less good effect using generics when there isn't any real evidence of that (or objective reason for it). It seems that in many countries, generic imatinib is already working fine.

None of this is a dig at the innovators - quite the contrary, I often say I owe my life to them and I believe they very often get an unfairly hard press. Developing a drug is hugely expensive to do and we want that both compensated and more so new drugs are developed. However, the NHS needs generics or the budget for newer medicines (such as ponatinib for CML and others for other currently untreated or poorly treated diseases) simply isn't there. Room needs to be made for these drugs - and indeed we want them to be invented and produced. So when imatinib goes generic in the EU in 2016, I fully expect a switch in the UK. Physicians generally have to prescribe generically in the UK and there need to be very good, patient specific reasons to do otherwise. And I would not be at all surprised if NICE or whoever it is by then reviews guidance for CML drugs since generic imatinib will radically alter the cost situation. That does not mean anything will be less available so not to be concerned - but my guess would be that there will be a renewed onus on prescribing imatinib first, in turn placing more importance on early monitoring to identify patients who may need newer generation drugs. That's just my guess but I can see something like it coming.

So, as an imatinib user personally I would not be concerned about generics coming in a couple of years, absent some compelling evidence that the particular generics approved for use in the EU are not in fact good enough.

Richard