Pfizer launches biosimilar Rituxan trial

Pfizer Inc. (NYSE:PFE) unveiled details Tuesday of its biosimilar rituximab program, including the start of a Phase I/II trial in rheumatoid arthritis patients comparing the candidate's pharmacokinetics, pharmacodynamics and safety to that of versions of rituximab sold in the U.S. and Europe. Started in March, the REFLECTIONS B328-01 trial will be conducted globally in 210 patients and is expected to finish in December 2013, Pfizer told BioCentury. Pfizer plans to conduct an additional efficacy study in RA, and expects to also study the candidate, PF-05280586, in one or more cancer indications. Pfizer said it plans to seek marketing approval of PF-05280586 in Europe and the U.S.

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 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. ...