Chronic Myeloid Leukemia patients call for quality and consistency when generics are introduced to treat their cancer

On 2-4 May 2014, patient organisations from 58 countries supporting patients and families affected by Chronic Myeloid Leukemia (CML) met in Serbia to learn from medical experts, share best practice in patient advocacy and grow their organisation's capacity. An important topic of increasing attention discussed between patients and health professionals was the introduction of generics in CML treatment. Patients welcome that generics may improve patient access to more affordable therapies in many countries. However, patients also raise concerns about impact on their cancer when switched between different products for non-medical reasons, if these products’ equivalence in terms of quality and efficacy is uncertain.

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Los pacientes con Leucemia Mieloide Crónica exigen calidad y regularidad ante la introducción de medicamentos genéricos para tratar este cáncer

Entre el 2 y el 4 de mayo de 2014, organizaciones de 58 países que apoyan a pacientes y familiares afectados de Leucemia Mieloide Crónica (LMC) se reunieron en Serbia para aprender de médicos expertos, compartir buenas prácticas en la defensa del paciente y aumentar las capacidades de sus organizaciones. Un tema de creciente relevancia entre pacientes y profesionales de la salud fue la aparición del uso de genéricos para el tratamiento de la LMC. Los pacientes celebran que los medicamentos genéricos puedan hacer más accesibles las terapias en muchos países. Sin embargo, también plantean su preocupación acerca del impacto que éstos pueden tener en su tratamiento cuando se les cambia el medicamento entre diferentes productos por razones no médicas, especialmente si la equivalencia entre estos productos en términos de calidad y eficacia es incierta

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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

2016-08-26 16 21 01-Leukemia - Chronic myeloid leukemia patients call for quality and consistency whMarket 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":

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:

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 let us know so we can share it!

 

"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.

 

Glossary

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.

 

 

 

 

Glossary on Generics

This page explains some frequently used terms and definitions in the area of generics. Please let us know if you are missing specific terms.

TERM
 DEFINITION
Compound Name Name of the active ingredient contained in a pharmaceutical product, e.g. Imatinib, Dasatinib, Nilotinib, Bosutinib, Ponatinib, etc.
Brand Name, or
Trade Name
Name under which a drug is marketed, e.g. Gleevec, Sprycel, Tasigna, Bosulif, Iclusig, Anzovip, Glimatinib, Veenat, Biotinib, etc.
Original drug, or
Patent-protected drug, or
Innovator product
'Original' drug marketed by companies that developed the drug and thus 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 A drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and efficacy, and intended use. A generic drug can only be marketed after patent & exclusivity protection ends.
Counterfeit drug Medicine that is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products. Counterfeit products may include products with the correct ingredients or the wrong ingredients, lacking active ingredients, with incorrect quantities of active ingredients, or fake packaging.
Substandard drug Products whose composition and ingredients do not meet the correct scientific specifications and which are consequently ineffective and often dangerous to the patient. Substandard products may occur as a result of negligence, human error, insufficient human and financial resources or counterfeiting.

 

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!

CML TKI Register

CML TKI Register for original and generic TKIs

We have compiled an inofficial directory including all CML Tyrosine Kinase Inhibitors, that are - to our knowledge - available to date.

See our inofficial CML TKI Register here.

It 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 documents (summaries of the European Public Assessment Report (EPAR), bioequivalence studies and manufacturer´s instructions).

All information is based on data provided by EMA (European Medicines Agency), the FDA (US Food and Drug Administration), on informal community submissions, and on data collected in our recent CML Advocates Network Survey on generics.

The register only covers Tyrosine Kinase Inhibitors so far, but might be extended to other types of CML drugs in the future.

This is a community-driven initiative - please contribute and share!

This CML Drugs Index is a community-driven initiative - which has no claim for completeness (and given the complexity of the generics market, it will always be best effort only)!

Therefore, your contribution with additional or corrected data is essential! We look forward to receiving your updates on approval status, availability of new and known generics in your country, and on products newly approved by your local competent authorities.

Please help us keeping this file up to date and filling it with life! If you wish to suggest any corrections or if you have additional information, please make sure you contact our Programme Manager Celia Marín at

This is non-commercial!

This is a purely patient-driven, non-commercial initiative. It has no interest to promote, or assess, any of the drugs. The only intent is to increase transparency in a confusing environment.

 

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