FDA Accepts Application for Rituximab Biosimilar

September 12, 2017 – The FDA has accepted a biologics license application (BLA) for the rituximab biosimilar (GP2013), according to Sandoz (Novartis), the company developing the treatment. If approved, rituximab biosimilar (GP2013) would be indicated for the hematologic malignancies follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL), as well as for rheumatoid arthritis. In June, the European Commission … (leggi tutto)