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CML Advocates Network survey on generics, copies and substandard drugs in CML
  1. Imatinib, dasatinib and nilotinib are a tyrosine kinase inhibitors (TKIs) that have been established as effective therapies in chronic myeloid leukemia. While imatinib (marketed as Gleevec/Glivec), and in some markets nilotinib (marketed as Tasigna) as well as Dasatinib (marketed as Sprycel), have been available for some years, non-original copy versions of these drugs have also been provided to CML patients in a number of countries. With the patent ending on Glivec from 2013 in some markets, use of generic TKIs in CML is becoming more and more widespread.

    With the CML Horizons 2013 patient conference putting a spotlight on the situation of generics and copies in CML, this survey intends to understand the availability of original TKIs and other non-original TKIs for the treatment in CML in countries all across the globe. It also aims to understand how CML patient groups are addressing the issue of quality assurance when generics become available.

    The results of this survey will be presented to the community at the CML Horizons 2013 meeting in May. It should take 10 minutes of your time to complete the survey. We would like to cover as many countries as possible - your contribution is greatly appreciated and will help us a lot!

    Can you please respond latest by 12 April 2013? Many thanks!

    Note/ Definitions:
    • Compound Name= name of the active ingredient in the pills, e.g. Imatinib, Dasatinib, Nilotinib, Bosutinib, Ponatinib, etc.
    • Name of the marketed drug= e.g. Gleevec, Sprycel, Tasigna, Bosulif, Iclusig, Anzovip, Glimatinib, Veenat, Biotinib, etc.
    • Original/ patent-protected drug= 'original' drug marketed by companies that hold the patents for Gleevec, Sprycel, Tasigna, Bosulif in many countries (e.g. Novartis, BMS, Pfizer, Ariad)
    • Copy drug= drug provided by third party manufacturers despite the drug is still patented
    • Generic drug= drug provided after the patent has expired in the country
    • Substandard drug= drug provided that has been documented to be falsified/counterfeit (e.g. pills not containing active ingredient or appropriate formulation)
    This survey is run by the CML Advocates Network without any commercial interest and without support from any pharmaceutical company.

  2. Q1. Please provide some data about yourself and your organisation.
    We will only use the name of your country in overall statistics. We will keep your data confidential - your name, your organisation and your email address will only be used by us to contact you if we (the CML Advocates Network) have further questions.
  3. Your name(*)
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  4. Your organisation or institution(*)
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  5. Your email address(*)
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  6. Your Country(*)
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  7. Q2. Which Tyrosine Kinase Inhibitors (TKIs) for treating CML are available in your country?
    Here we also want to know about all drugs - the original drugs, copies, generic versions and substandard versions of TKI drugs to treat CML. Please enter the compound name (e.g. Imatinib, Dasatinib), the corresponding brand name (e.g. Gleevec, Veenat, Imatib, Biotinib, Anzovip, etc) and the manufacturer (e.g. Novartis, Natco, Sun etc). We would also like to know in which country the drug is manufactured (leave field blank if information is not available).

  8. Drug 1
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    Country of Manufacturing(*)
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    Drug 2
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    Drug 3
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    Drug 4
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    Drug 5
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  9. Q3. For the drugs mentioned above, has any certificate of quality, proof of "bioequivalence" in CML patients, or proof of effectiveness in CML patients been provided to you and/or the public?
  10. Drug 1:Compound Name
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    Brand Name
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    If yes, please describe documentation
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    Drug 2:Compound Name
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    If yes, please describe documentation
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    Drug 3:Compound Name
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    If yes, please describe documentation
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    Drug 4: Compound Name
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    If yes, please describe documentation
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    Drug 5: Compound Name
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    Brand Name
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    If yes, please describe documentation
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  11. Q4. Are generic versions, copies or substandard versions of TKIs available in your country?
  12. (*)

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  13. Q5. For how long have CML patients in your country been receiving generic, copy or substandard versions of CML drugs?
    (This question does NOT address the original/patented drugs from Novartis, BMS, Pfizer, Ariad, but copies or generics from other manufacturers)
  14. in months (approximately)(*)
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  15. Q6. Has a generic, copy or substandard TKI drug been registered by the health authority or medicines authority in your country (national authority similar to FDA, Japanese Medicines Agency, etc)?
  16. (*)


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  17. Q7. Have you or local hematologists made any observation on the generic, copy or substandard TKI drugs in terms of unusual side effects or efficacy, when comparing with what responses or side effects would be expected on original/patent-protected TKIs?
  18. Drug 1
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    Drug 2
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    Drug 4
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    Unusual side effects / efficacy
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    Drug 5
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    Unusual side effects / efficacy
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    Q8. Has your patient organisation or institution taken any action in the country on generics, copies or substandard drugs in CML, e.g. asking national health authorities or medicines authorities for written evidence on quality, working with third parties on assessing quality of the tablets, or any campaigning in the public?
    If so, can you please describe your initiative here:
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  20. Q9. Is the registration of any generic, copy or substandard TKI is currently being prepared in your country?
    If yes, please name the compound name, brand name and manufacturer (if information is available): (*)


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  22. Drug 1
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    Drug 2
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    Drug 3
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    Drug 4
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    Manufacturer
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  23. Q10. Do you have any other comment for us?
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  25. Thank you very much for your feedback which we greatly appreciate! We will share the results with the community.
  26. * Required field

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