Counterfeiters in Europe are displaying a fondness for mimicking high-priced Roche cancer drugs. For the second time in 5 months, authorities there have uncovered fakes, and the two cases appear not to be connected.
The Swiss drugmaker ($RHHBY) said in an email Monday that counterfeit vials of its top-selling blood cancer drug MabThera had been found in Germany. MabThera, sold as Rituxan in the U.S., is Roche's best-selling drug and the best-selling cancer drug in the world, with 2013 revenues of $7.78 billion.
"Roche was alerted that counterfeit MabThera (rituximab) was detected in Germany by a German parallel importer," the company said. "Roche can confirm that all product associated with the batch in question was distributed by Roche to wholesalers in Romania. Once the product in question reached the wholesaler network, Roche has neither further control nor knowledge of the events that may have transpired." It said there was no evidence any patients had been harmed by the fakes.
The company also said that it was unaware of any link between these developments in Germany and recently reported counterfeiting and tampering of products with Italian packaging. Some of those compromised vials were found in Germany, but also in Britain and Finland. In that case, testing determined that some of the Herceptin vials, which came with falsified records, did not contain the injectable cancer drugs' active ingredient. Others had it but showed signs of tampering or dilution.
In 2012, the FDA found that fraudulent versions of Roche's cancer treatment Avastin had been sold to physician practices throughout the U.S. The FDA and the Department of Justice have also been prosecuting a number of cases in which versions of drugs manufactured for foreign markets but unapproved in the U.S. have been sold to American physician practices--including some of Roche's cancer meds.
- read the Reuters story