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IMTINIB (GLEEVEC) and generic

What deferant between IMATINIB (GLEEVEC) (NOVARTIS) AND GENERIC...???

IMATINIB WORK SUPERB... (MY EXPERIENCE)

GENERIC WORK????

IMATINIB BETTER THAN GENERIC???

GENERIC WORK ALSO GOOD??? Yes / no

GENERIC DRUG SIDE EFFECTS???
PLEASE REPLY

PLEASE SHARE YOUR ADVICE AND EXPERIENCE.....

Vikram there is a leaflet here which explains about generics.

Simple answer is that Novartis developed imatinib and sold it as Glivec/Gleevec while it was still under patent. When the patents expired (slightly different times in different countries) other companies could start to make it, and it is cheaper for health providers to buy. The active ingredients are exactly the same in glivec and the generic; there may be other compounds in the pills which differ. The only difference I found was that the Wockhardt generics I took tasted horrible. I didn't have any other issues with it. Some people have found the generics cause more side effects. Sandoz is a brand of generics which is part of Novartis, so that is likely to be the generic which most like Glivec. Changing from imatinib to a generic made no difference to my PCR result.

Hope this helps

Hi All,

The most informative difference I have gleaned between the branded glivec and the generics which followed the expiry of patents held by Novartis is from the site of the CML Society of Canada and can be summarised thus:

The branded imatinib mesylate Gleevec or Glivec as we in UK know it uses a beta formulation of imatinib mesylate whereas each generic version uses different excipients i.e. a bulking agent added to the active pharmacological ingredient for the purpose of aiding in the manufacturing and/or helping with the drug solubility and absorption.

The generics use different excipients and are a different formulation of the original molecule. Bioequivalence studies undertaken in Canada suggest that the different formulations of alpha and the  original beta formulation should work (in vivo) within the body equally well.

Some criticisms of the decision in 2013 by Health Canada to go ahead for health providers /insurance companies with the generic versions were:

-the original beta formulation of Novartis or the branded version was subject to clinical trials with actual  CML patients

-the subsequent safety checks made on Apotex and Teva versions used in Canada did not involve actual clinical trials nor did they involve actual CML patients but given to fit and well volunteer or paid persons to basically test if they were safe.

My haematologist advised me that if I was ever forced to go on to a generic (currently the insurer supports me to continue with the original branded Glivec) to only use Sandoz and at all costs avoid switching from generic brand to brand. I would ask whether Sandoz uses the original beta formulation of the molecule or whether they use an alpha formulation.

The key tests would be whether PCR levels were affected and whether different side effect profiles emerged as a result of the different use of alpha formulations.In the province of Quebec physicians if they had concerns for the patient could write on a prescription "do not substitute" for the original branded drug so if they did this was there  evidence of different effects on patients between use of the original branded Glivec and subsequent generic versions.?  Health Canada allowed this situation of different policies between Quebec and the other provinces. Any comments?

I am not a pharmacologist but if my PCRs started rising or if the side effects after starting on a generic were horrific then  I would be asking for more evidence from the FDA and EMA as well as my national regulatory authority.

Regards

John

I raised this matter using the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) Yellow Card scheme. Here is an extract from the MHRA response. My main problem was with the generic ACCORD. I assign each generic a fig factor. Taking Accord is like taking imatinib with six figs whereas Cipla is worthy of four figs and taking Sandoz is more like two figs.

You asked why Accord is different from other generic versions of imatinib. We wish to highlight that generic medicines, such as Accord imatinib are granted a licence following a study to demonstrate that the medicine is bioequivalent to the reference medicine (a medicine which already has an established license). Two medicines are bioequivalent when they produce similar levels of the active substance in the body (usually measured in the blood). The degree of difference allowed is defined by ‘European bioequivalence guidelines’ which state: small differences in blood levels can occur. Therefore, when comparing between two generic medicines, they will have shown bioequivalence to the reference medicine and therefore to each other. However, it may be worth highlighting that the production of the medicinal products and product excipients may differ slightly between generic products, however these differences should not impact the safety profile of the product. Therefore, although active substances are the same between generic medicines, the excipients which make up the medicine may vary and certain individuals may react to specific excipients within a medicine. You may find it useful to know that a full list of excipients in each medicine can be found in Section 6 of the PIL.

 

 

I have been on generic imatanib made by Teva, Sandoz and one other (I forgot the name)

I had NO difference in results with any of them but I preferred Sandoz because the Teva pills are huge and the other manufacturer gave me nausea a litte more often (I get rarely).

Imatanib IS the generic name of Glivec. I've been taking Gilvec recently but I dont like their capsule formulation so much, perhaps I'm just used to the compressed tablet. Note I also took the Indian generic Veenat for awhile, it had the same effect but caused me much more often nausea. 

 

 

Hi all

Very interesting and informative discussion!

My two cents' worth: I have been on several different generics of imatinib and am currently on Mivesta. According to my doctor, this is the generic with the most extensive FDA testing and support and she guarantees me that it is as powerful and effective as Gleevec. On this one my PCR result has continued to drop and I don't have major side effects.

Strangely, ACCORD gave me a GREAT deal of side effects. It caused such bad heartburn that I used to wake up at night, no matter what I ate. I found this out by accident because I still had some of the other generics left over - upon switching for a day, the heartburn stopped and was back immediately when I restarted the ACCORD. As a result I requested to be changed to a different generic and the Mivesta has been brilliant (as has another one called Imavec which now seems hard to get in South Africa).

Good luck to everyone!

Regards

Martin