Roche warns of fake MabThera in Germany

MabTheraRoche has confirmed that counterfeit versions of its big-selling cancer and arthritis drug MabThera have been discovered in Germany.

News that MabThera (rituximab; also sold as Rituxan) has been targeted by counterfeiters comes just a few months after the Swiss drugmaker revealed that illicit, tampered copies of its breast cancer drug Herceptin (trastuzumab) were also circulating in the EU market after a theft in Italy.

Illicit copies of MabThera and another of Roche's cancer drugs called Avastin (bevacizumab) were also discovered in the US and several European markets in 2012 and in China a year earlier.

MabThera is used to treat non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukaemia (CLL) and was Roche's biggest-selling drug last year with sales of almost $7.5bn.

The MabThera counterfeits were originally distributed in Romania and were discovered by a parallel importer, which was repurposing the product for sale in Germany.

Parallel traders take advantage of the different prices of medicines between EU countries, buying stocks in low-priced markets and selling them at a discount in markets where prices are higher. Often the drugs have to be repackaged to comply with the requirements of the destination country – for example the inclusion of a label and patient package insert in the correct language.

In a statement, Roche said that "once the product in question reached the wholesaler network, Roche has neither further control nor knowledge of the events that may have transpired."

This is not the first time that parallel traders of medicines - which are licensed to repackage medicines - have discovered fake medicines in the supply chain.

A member of the industry's trade body, the European Association of Euro-Pharmaceutical Companies (EAEPC), was responsible for detecting the counterfeit versions of schizophrenia drug Zyprexa (olanzapine) that penetrated the UK supply chain in 2007.

After years of opposition between brand-name medicine manufacturers and parallel importers the two groups are now working alongside each other on the European Stakeholder Model (ESM) medicines verification scheme.

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