Roche's MabThera Approved In The EU

Hoffmann-La Roche says that it has received approval from the EuropeanCommission to market its anti-CD20 monoclonal antibody MabThera (rituximab) for the treatment of relapsed or chemoresistant follicular B-cell non-Hodgkin's lymphoma. The company says that it intends to make the drug available in the UK and Germany in the next couple of weeks, with launches in the remaining member states to follow thereafter.

Rituximab was discovered by US firm IDEC Pharmaceuticals which developed the product in collaboration with Genentech, Roche and Zenyaku Kogyo of Japan. IDEC and Genentech copromote rituximab in the USA, where it is sold under the brand-name Rituxan, while Roche is responsible for marketing the product in the rest of the world with the exception of Japan.

Rituximab was first launched at the end of last year in Switzerland, where the cost to the consumer is 2,433.70 Swiss francs ($1,698) for the 500mg size and 1,622.85 francs for the 100mg size. European Union pricing has not yet been disclosed. The product is supplied at a concentration of 10mg/mL in either 100mg (10mL) or 500mg (50mL) single-use vials (Marketletter December 8, 1997).