More fake Avastin found in EU, thanks to FMD scanning

Another falsified batch of Roche’s cancer drug Avastin has been discovered by a wholesaler in the Netherlands.

Four boxes of the product – in Bulgarian packaging – were found at an as-yet unidentified Dutch pharmaceutical wholesaler, according to an alert issued by the Dutch Health Care Inspectorate IGJ (Inspectie voor Gezondheidszorg en Jeugd).

The falsification came to light when a wholesaler scanned a box in the context of the new system of safety features that has been in force since February 2019. When scanning, the wholesaler was notified of a possible counterfeit – and this is one of the first times on public record that the verification system put in place as part of the Falsified Medicines Directive (FMD) in February has protected patients from being exposed to potentially fake drugs.

The falsified packages were intercepted before they reach pharmacy shelves, says the agency, so patients should not have been exposed to the illicit product. Avastin is a multibillion blockbuster antibody prescribed for a broad range of solid tumours, including colon, breast, lung, kidney, and cervical cancer.

Een groothandel in Nederland heeft vier vervalste flacons van het kankergeneesmiddel Avastin ontdekt en heeft dit gemeld bij IGJ. Deze geneesmiddelen zijn nog voordat ze de apotheek bereikten onderschept. Ze zijn niet toegediend aan patiënten. https://t.co/HAjGIdMLL1

— Inspectie Gezondheidszorg en Jeugd (@IGJnl) June 26, 2019

The latest incident follows a number of previous cases in which counterfeit Avastin has been identified in the EU medicines supply chain, in some cases in Turkish packaging with the brand name Altuzan.

According to the IGJ, it is not clear whether the suspect Avastin is genuine medicine in a different package, or an actual counterfeit that may not contain any active ingredient. The investigation into the batch is still ongoing.

“The inspectorate in any case regards the medicines in question as falsified, because they have been out of the legal chain and therefore out of sight of our supervision,” said the IGJ.