Counterfeits Of Roche's MabThera Discovered In Germany

Last week, counterfeit vials of Roche’s MabThera were discovered in Germany. This is the second time this year that Roche’s drugs have been targeted by counterfeiters, Reuters reports.

MabThera is an injectable biotech drug indicated as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with the drug plus chemotherapy. Also known as Rituxan, the drug is used to treat rheumatoid arthritis as well. MabThera was Roche’s highest seller last year, bringing in $7.45 billion in sales.

The company reported that the suspect drug batch was originally distributed to wholesalers in Romania. One vial was shown to have a reduced amount of MabThera’s active ingredient, while others had missing or tampered caps, missing information material, or inconsistent batch numbers. Roche stated that it was not aware of any existing link between the compromised vials found in Germany and the reported compromised and counterfeited products with Italian packaging.

It isn’t a surprise that counterfeiters would target this drug in particular, as they stand to make a solid chunk of change off of the counterfeits. According to the Wall Street Journal, a 50-milliliter vial of the drug costs roughly $1,416 in the U.K., making theft of the cancer drug a sizable moneymaking venture.

“Roche was alerted that counterfeit MabThera was detected in Germany by a German parallel importer… Once the product in question reached the wholesaler network, Roche has neither further control nor knowledge of the events that may have transpired,” Roche explained in an emailed statement.

Earlier this year, the company also reported the counterfeiting of its product Herceptin in several European countries after some drug vials were stolen in Italy.

The World Health Organization (WHO) classifies drug counterfeits in six categories: drugs without active ingredients (32.1 percent), drugs with the wrong amount of the active ingredient (20.2 percent), drugs with wrong ingredients (21.4 percent), drugs with correct amount of active ingredient but with fake packaging (15.6 percent), copies of original drugs (1 percent), and drugs with high levels of contaminants and impurities (8.5 percent). According to the Centers for Disease Control and Prevention (CDC), drug counterfeiting often takes place in countries where the rules governing drug development and production are few or sketchy. Around 10 to 30 percent of drugs sold in developing countries are considered to be counterfeit.