September 12, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Pharma giant Roche has been hit by counterfeit drugmakers for the second time in a year, after the company said Friday it had found compromised vials of its blood cancer drug MabThera being sold in Germany.
The cancer and rheumatoid arthritis drug is a huge earner for the Swissmaker, which markets it as Rituxan in the U.S. and elsewhere, and netted $7.5 billion from its sale in 2013.
“Roche was alerted that counterfeit MabThera was detected in Germany by a German parallel importer,” the drugmaker said in an emailed statement, adding it had originally distributed batches of it to wholesalers in Romania.
“[But] 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.
German officials involved in the investigation said main of the vials had missing or tampered with caps, and one contained a diluted amount of the drug’s active ingredient.
The incident is the second counterfeiting problem for Roche in less than six months, after an alert was issued in April by the European Medicines Agency that vials of its breast cancer drug Herceptin (trastuzumab) were stolen in Italy and later turned up in the United Kingdom, Finland and Germany.
“Patient safety is our primary concern,” Roche said in a statement at the time.
“The implications of this illegal activity may have serious consequences for public health which is why are fully committed to working with the appropriate health authorities and law enforcement agencies to aid their investigations to determine the source of the counterfeit medicine, and prevent its further distribution.”
