EMA confirms Roche's MabThera made at Vacaville site poses no health risk

28 May 2012

Following a quality review of the genetically engineered monoclonal antibody MabThera, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the batches of the active substance of Swiss drug major Roche’s (ROG: SIX) blockbuster drug MabThera (rituximab) produced at the Vacaville manufacturing site in the USA do not present a risk to public health.

MabThera/Rituxan, which generated first-quarter 2012 sales of 1.61 billion Swiss francs ($1.7 billion), is indicated in non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma), chronic lymphocytic leukemia (CLL) and rheumatoid arthritis.

Contaminant not seen at later stages of manufacturing

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