Falsified Iclusig / ponatinib traded globally

The World Health Organisation (WHO) recently released an alert about batches of ponatinib (Iclusig) that are not authentic.

The technical description of drugs that are not authentic is that they are “Falsified Medicines”.

This situation has similarities with counterfeit versions of well known brands of clothing, trainers or perfumes you sometimes see for sale in street markets at prices way below those for the same products advertised for sale by reputable high street retailers.

The similarities end once the impact on a patient taking a falsified medicine for a condition like CML is factored in.

We have noticed that news of the WHO alert has now spread across CML patient groups worldwide including some of the more informal Facebook groups. 

To a question like “Should UK CML patients being treated with, or being considered for treatment, with ponatinib be concerned about receiving a falsified rather than authentic product?” our answer would be a definitive “No”.

The same answer we gave when similar concerns were initially raised about generic versions of imatinib in 2017.

We have every confidence in the effectiveness of the relevant UK regulator, the Medicines & Healthcare products Regulatory Agency (MHRA), in policing the marketplace for medicines in the UK.

We have also be in contact with UK office of Incyte, the company that has ponatinib in its portfolio of drugs, who have confirmed they remain in active, ongoing contact with the MHRA about this issue. The same applies with similar regulatory organisations across the EU in addition to the WHO. 

To date no counterfeit product has been reported to be in circulation within any EU member state with trading of the counterfeit product currently only detected in Turkey, Argentina, Malaysia and, inevitably, via internet sales.

A further source of reassurance is that Incyte's supply to the NHS is via a single distributor who in turn receives batches directly from the manufacturer contracted by Incyte to produce ponatinib.

We remain confident that, taken together, all these factors make for a totally safe, counterfeit free environment for ponatinib in the UK.

See this link to the WHO for a detailed description of the counterfeit batches: 

https://www.who.int/medicines/publications/drugalerts/drug_alert-2-2019/en/

Finally, should any patient have concerns about their ponatinib tablets, Incyte have a medical information contact point so that a patient can check that the codes on the pack they have are genuine product. Contact details for Incyte European Medical Information department are: 00 800 00027423 or 01423 533517 or e-mail them at eumedinfo@incyte.com