Fake Avastin reignites "Track-and-Trace" debate, but the clock is ticking

The US Food and Drug Administration announced in February that counterfeit vials of Roche/Genentech’s cancer drug Avastin (bevacizumab) were sold to a number of medical practices across the country (The Pharma Letter February 16), notes intelligence provider GlobalData.

While the exact sources of the phony drug remain a mystery, authorities traced the fake batch through several distributors throughout Canada, the UK, Denmark and Switzerland to only end up with an unlicensed supplier in the Middle East as the possible culprit. When tested, the phony batch did not contain any bevacizumab, the active ingredient in Avastin, which was substituted with salt and starch. Along with fake batch numbers, the drug packaging was also counterfeit, bearing Roche’s name and French labelling, contrasted to the authentic Avastin packaging which imprints Genentech’s name and has English labelling.

Making matters worse, says GlobalData, in April the FDA issued a second warning that it had discovered a new batch of counterfeit Avastin circulating throughout the USA, under the name Altuzan, the brand name for Avastin marketed in Turkey, which is not approved for use in the USA. The FDA stated that nearly 50 physician practices in the USA, mostly in California, had bought the fake Avastin from supplier Ban Dune Marketing. This was quite interesting, considering that authorities shut down the La Jolla-based distributor last August. The company’s founder and president, James Newcomb, was indicted by the US Attorney’s Office in St Louis for selling counterfeit versions of Herceptin, Neupogen and Rituxan, other expensive cancer drugs.