CML Generics Declaration

Resource & Knowledge Center on CML generics, copy drugs & substandard drugs

Welcome to our “Resource & Knowledge Center” on CML generics, copy drugs and substandard drugs. The Resource & Knowledge Center intends to pull together all information that is known to us to date. If you have additional information or feedback, please make sure you contact us at!

Declaration of the CML community

Market exclusivity for imatinib has expired in most countries between 2013 and 2016. CML patients have been increasingly exposed to generics and copy drugs in the treatment of CML, raising concerns about outcomes when patients are switched between products for non-medical reasons.

A survey of patient organisations and physicians by the CML Advocates Network in 2013 determined that generic imatinib and dasatinib were available in 32 countries. In 2014, CML patient organizations released a declaration, calling for quality and consistency when TKI generics are prescribed, demanding data on bioequivalence and clinical equivalence to the originator drug. Patients should not be switched between products with the same substance for non-medical reasons. If a switch is enforced, it should not happen more than once a year, with sufficient follow-up assessing safety and efficacy. In case of loss of response or increase in toxicity after switching, switching to the previous treatment or another treatment should be allowed. More frequent molecular monitoring post-switch should allow early detection of differences in effectiveness or toxicity. These recommendations by the patient community may support experts’ discussion on CML management with TKI generics.

The CML Generics Declaration has been published as an open-access article in the renowned journal LEUKEMIA, doi: 10.1038/leu.2016.220. Read the declaration here. It is also available in Spanish.

Webinar on TKI Generics in CML

This webinar by the CML Advocates Network, published in December 2016, answers some important questions, such as:

  • What are generics, and do they differentiate from innovator products?
  • Which generics of CML Tyrosine Kinase Inhibitors exist?
  • What do we know about efficacy and safety?
  • What information on CML generics is available to patients?
  • What has the patient advocacy community done so far?
  • What can patients and patient advocacy groups do about CML generics?

If you want access to the slides, please contact Jan Geissler at

CML TKI Register

We have compiled an inofficial directory including all CML tyrosine kinase inhibitors (TKIs) that are – to our knowledge – available to date. Our CML TKI Register provides information on the product name, compound name, registration status of all TKIS available on the international markets, the name of the respective manufacturer and / or Marketing Authorization Holder (MAH) and the specific indication of each drug. If available, it also provides links to publicly available documentation.

Session at CML Horizons 2015:
“Advocating on generics and fighting for quality of care”

Please see the videos and PDF files and web streams of our session at “CML Horizons 2015”:

Introduction: How are drugs approved and monitored? (Nicole Schröter) – PDF & Web Stream
CML TKI register & Declaration on Generics (Jelena Čugurović) – PDF & Web Stream
Debate: Going from fear to action – what can advocacy do? (Pat Garcia-Gonzalez, Sandra Shaw, Jelena Čugurović, Hari Menon) – Web Stream

Session at European Hematology Association (EHA) Congress 2014:
“Generics in Haematology: The doctors’ and patients’ perspective”

This session in the EHA’s Patient Advocacy Session, which the CML Advocates Network co-coordinated, addressed the issue of drug quality in generics, substandard drugs and copies from a pharmacology perspective, how the issue of drug quality is being addressed with governments, how the change to generics is being handled on a clinical level by hematologists, and the challenges and opportunities from a patient perspective.

  • Drug quality in generics, substandard drugs, copies – the pharmacologist perspective (Dr Atholl Johnston, UK) – PDF
  • Use of generic drugs and discussions with the government on drug quality (Dr Mehregan Hadipour, Iran) – PDF
  • The hematologists’ clinical perspective (Dr. Ivana Urosevic, Serbia) – PDF
  • The patients’ perspective (Sarunas Narbutas, Lithuania) – PDF

Session at CML Horizons 2014:
“The new realities: Generics and Copy Drugs in CML”

Please see the videos and PDF files of our session at “CML Horizons 2014”:

  • Generics, copies & substandard drugs, How to assess quality of drugs and labs
    (Prof. Yoseph Caraco, Pharmacologist) – PDFVideo Stream
  • CML generics from a patient perspective
    (Cheryl-Anne Simoneau, CML Society of Canada) – PDFVideo Stream
  • CML generics from a hematologist perspective
    (Dr. Andrija Bogdanovic, Serbia) – PDFVideo Stream
  • CML generics from a hematologist perspective
    (Dr. Qian Jiang, China) – PDFVideo Stream

Session at CML Horizons 2013:
“Ideal World vs. Reality: New Challenges with Substandard Drugs & Generics”

Please see the videos and PDF files of our session at “CML Horizons 2013” which was addressing the new challenges with substandard drugs, copies and generics in CML. We are also sharing the Excel summary of the data collected in our generics survey in March 2013:

  • Generics, biosimilars, copies, substandard drugs: efficacy, efficiency, sustainable quality? What is the difference? (Sabine Kopp, Medicines Quality Assurance Programme, WHO)
    PDFVideo Stream
  • Originals, generics, copies: Results of the CML Advocates Network Survey (Jan Geissler, CML Advocates Network):
    PDFVideo stream – Detailed summary of survey data (Excel) – Survey questions
  • Actions of CML groups: Fighting against Anzovip, a generic drug (Jelena Cugurovic, Serbia)
    PDFVideo Stream

Scientific publications on efficacy and bioequivalence of generic and copy drugs in CML

We are collecting all scientific publications and other credible articles that give some evidence on the quality, bioequivalence or efficacy of generic CML drugs or copy drugs. Please see the list of publications that are known to us to date. If you come across additional publications, please mailto!

“What´s in the news?” A compilation of newspaper articles and reports related to generics and copy drugs in CML

Please visit our latest sub-section! In this new section we are collecting all newspaper articles and reports on generic CML drugs or copy drugs. Please see the current list of articles here. This sub-section lives only if you make it grow! So please share all articles related to CML generics and copy drugs that you come across!

“Best Practice Toolbox” for patient advocacy on generics, copy drugs and substandard drugs

We invite our CML Advocates Network members to check out our newly created “Best Practice Toolbox on CML Generics” (for registered members, after login only). The Toolbox intends to provide CML patient groups with some guidance on advocacy initiatives that they may consider when planning activities on generics in your country. We will get started with a toolbox provided by our members organisation CML Association of Serbia who kindly accepted our invitation to share their experience in how to advocate for quality drugs in CML. This is a community-driven initiative and intended to grow over time.


See our brief generics glossary that explains some key terms and definitions in the area of drugs and generics. Please also have a look at our in-depth CML glossary that explains more than 400 terms used in CML-related medicine and regulatory affairs. Let us know if anything important is missing!

Blog on CML generics

CML Advocates Network members are invited to join our newly established blog on generics. Your experience as a patient advocate in addressing this new advocacy challenge is very valuable – pease share it with other members of our global network. Start blogging now! This blog is only available for CML Advocates Network members after login.