Teva: no trial yet for biosimilar rituximab
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) told BioCentury it has yet to begin a Phase III trial of its biosimilar version of autoimmune and cancer drug MabThera rituximab, citing "changes in the regulatory and competitive environment." According to the EU Clinical Trials Register, a planned ex-U.S. Phase III trial comparing the biosimilar to MabThera in rheumatoid arthritis was "prematurely ended" in August. Teva said it and partner Lonza Group Ltd. (SIX:LONN) are "evaluating the path forward" for the biosimilar. Teva did not disclose additional details, saying it would provide an update of its R&D portfolio review during its investor day on Dec. 11.
Patents on rituximab or its uses expire in the U.S. between 2015 and 2018, and in the rest of the world in 2013. Biogen Idec Inc. (NASDAQ:BIIB) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) co-market the product as Rituxan in the U.S., while Roche markets it as MabThera elsewhere. Rituximab is approved in the EU and U.S. to treat non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and RA, and to treat diffuse large B cell lymphoma (DLBCL) in the EU. Teva was off $0.26 to $40.53 on Thursday. Biogen Idec was off $0.37 to $152.57. Lonza was unchanged at CHF50.60 on Thursday. ...