Roche warns counterfeit Avastin now in US market

Roche subsidiary Genentech has said that counterfeit copies of its big-selling cancer drug Avastin which do not contain any active ingredient have been encountered in the US market.

Avastin (bevacizumab) has already been targeted by counterfeiters in China, with fake versions used off-label at a Chinese hospital specialising in eye disorders, leading to complications in dozens of patients (see NEJM publishes counterfeit bevacizumab details).

Now, illegal copies of the drug in 400mg/16mL vials have been identified as being distributed in the USA, where the drug is approved to treat various cancers, including those affecting the colon, lung, kidney and brain. Genentech has confirmed in laboratory testing that the copies are counterfeit and contain no active ingredient, placing patients at risk of treatment failure.

A Food and Drug Administration (FDA) notice advises that the counterfeit versions are in Roche rather than Genentech livery (Roche manufactures the drug outside the US) and display batch numbers that start with B6010, B6011 or B86017.

"The FDA-approved version does not include the Roche logo on the packaging or vials," said the agency in a statement.

At least 19 medical practices are thought to have purchased the fraudulent product from Quality Special Products, an overseas supplier that is also thought to operate as Montana Health Care Solutions.

Volunteer Distribution in Gainesboro, Tennessee, is a distributor of QSP's products, according to the FDA. According to Genentech, none of the suppliers mentioned by the FDA are authorised to distribute Avastin.

Interestingly, in India Roche has taken specific measures to help protect Avastin from counterfeiting and has seen good results in recent years. The company makes use of a system developed by Norwegian company Kezzler in India which allows patients to authenticate their own medicines by texting a 16-digit serial number printed on the pack to a central SMS number.

Roche implemented Kezzler's system five years and has not encountered any counterfeit Avastin in the Indian market in the last three years, according to a Kezzler spokesman.