BioCentury
ARTICLE | Company News

FDA reviewing Celltrion's Rituxan biosimilar

June 29, 2017 9:37 PM UTC

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) and Celltrion Inc. (KOSDAQ:068270) said FDA accepted for review a BLA for CT-P10, their proposed biosimilar of rituximab. Teva spokesperson Michelle Larkin told BioCentury the candidate's user fee action goal date is in February 2018.

Roche (SIX:ROG; OTCQX:RHHBY) and Biogen Inc. (NASDAQ:BIIB) jointly market the biosimilar's reference product, Rituxan rituximab, in the U.S., where it is approved to treat non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. Larkin declined to say whether Teva and Celltrion are seeking the biosimilar's approval in all of those indications...