FDA approves first biosimilar for NHL

FDA approved a resubmitted BLA for Truxima rituximab-abbs from Celltrion Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA). The agency said Truxima is the first biosimilar approved in the U.S. to treat non-Hodgkin lymphoma.

Truxima is indicated as monotherapy to treat adults with relapsed or refractory, low-grade or follicular CD20-positive, B cell NHL; as maintenance therapy for non-progressing NHL after chemotherapy; and in combination with first-line chemotherapy for previously untreated NHL. Truxima is a biosimilar of cancer and autoimmune drug Rituxan/MabThera from Roche (SIX:ROG; OTCQX:RHHBY)...