EMA warns of tampered, falsified Herceptin

Vials of Roche's breast cancer drug Herceptin - stolen in Italy - have been falsified and re-introduced into the EU supply chain, according to the European Medicines Agency (EMA).

The case looks like an example of how legitimate product can be diverted from the usual supply chain and undergo a process of falsification to maximise its value to the criminals behind the scam and make it easier to introduce it back onto the market.

The EMA is warning healthcare professionals to be on the lookout for vials of Herceptin (trastuzumab) with batch numbers and expiry dates that do not match those on the outer package.

Liquid may also present in some vials, although trastuzumab is presented as a white to yellow powder that is reconstituted in the vial. That - alongside evidence of tampering with rubber stoppers, crimping caps or lids on vials - suggests those behind the crime have interfered with the contents.

The falsified vials are labelled as Italian Herceptin 150 mg, according to an EMA alert, which notes that falsified medicines must not be used. The numbers of the Herceptin batches known to be affected - which have been recalled by Roche as a precaution - are H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09 and H4303B01.

Roche has also been targeted by counterfeiters for other products, notably its Avastin (bevacizumab) cancer therapy.

Italy a 'hotspot' for pharma crime

The Herceptin incident comes against a backdrop of a series of pharmaceutical thefts in Italy in recent weeks. Earlier this month armed thieves hijacked a cargo van carrying around $650,000-worth of pharmaceuticals near the town of Bitonto near Bari, while in March another $670,000 shipment was stolen from a trailer in Parto, North of Florence.

In February a truck with more than 30 pallets of medicinal products was hijacked by three gunmen in Cerignola, southern Italy, although most of that shipment was recovered in a warehouse in Naples.

A recent report from Transcrime indicated that between 2006 and 2013 10 per cent of all hospitals in Italy recorded pharmaceutical thefts with an average value per incident of €330,000 ($), for a total loss of around €18.7m.

Southern and eastern Italy seem to be the most affected by pharma thefts because of greater activity of organised crime groups and proximity to Eastern Europe and Greece, which seem to be common destinations for stolen drugs, according to Transcrime.

The report suggests that thefts are carried out by specialised groups that are able to "infiltrate or corrupt medical personnel wholesalers" and have "sufficient knowledge to identify, store, transport and place stolen products on illegal markets, in Italy and abroad."