Pfizer's biosimilar equivalent to rituximab in Phase III test
Pfizer Inc. (NYSE:PFE) said biosimilar candidate PF-05280586 met the primary endpoint of equivalence to rituximab on overall response rate (ORR) in the Phase III REFLECTIONS B3281006 trial to treat CD20-positive, low tumor burden follicular lymphoma in the first-line setting. The company declined to give details on its plans for regulatory submissions.
Rituximab is approved in the U.S. as Rituxan and in the EU as MabThera to treat certain types of CD20-positive non-Hodgkin’s lymphoma (NHL); CD20-positive chronic lymphocytic leukemia (CLL); rheumatoid arthritis; granulomatosis with polyangiitis and microscopic polyangiitis. Biogen Inc. (NASDAQ:BIIB) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) share rights to rituximab, a chimeric mAb against CD20 antigen...