Update: Second batch of fake Avastin found in US

The Food and Drug Administration has issued a second alert to healthcare practitioners about a counterfeit version of Roche's cancer drug Avastin (bevacizumab) which has been found circulating in the US supply chain.

The fakes - which are in packaging bearing the Altuzan trade name Roche uses in Turkey and the lot number B6021 - are thought to have originated from overseas and have been purchased by a number of US medical practices, according to an FDA alert issued yesterday.

The FDA has determined that the 400mg/16ml product (pictured) is counterfeit and contains no active ingredient, and appears to have arrived in the US via a different route to the earlier counterfeit Avastin case which was uncovered in February.

"Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the US," said the agency, although it notes Altuzan is an approved drug in Turkey.

Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI), according to the FDA.

In the earlier case the counterfeit Avastin appeared to have passed through Egypt, Turkey and wholesalers in Switzerland, Denmark and the UK before alighting in the USA. The UK Medicine and Healthcare products Regulatory Agency (MHRA) said it had evidence that the fake Altuzan also passed through the hands of a UK wholesaler, as in the first case, and was collaborating with the FDA on its investigation into the incident.

Roche and subsidiary Genentech said that they were aware of the incident and were cooperating with the FDA's investigation.

BDMI closed down last August, according to a Wall Street Journal report, which notes that two of the company's executives were indicted in January for selling adulterated versions of a number of biologic drugs, including Roche's Herceptin (trastuzumab) for breast cancer, Amgen's white blood cell stimulator Neupogen (filgrastim) and Biogen Idec/Genentech's cancer and arthritis drug Rituxan (rituximab).

Some of the medicines distributed by the company also bore Turkish branding, although there is no suggestion at present that they were counterfeit.

BDMI's owner James Newcomb and employee Sandra Behe pleaded guilty to the charges and are due to be sentenced in May. An oncologist who purchased drugs from BDMI - Dr. Abid Nasir - has also pleaded guilty to ordering an unapproved medicine from the firm.