- The P-I/III (NCT02792699) study involves assessing of ABP 798 vs Rituxan (rituximab, IV) in 311 patients in the ratio (1:1:1) with moderate-to-severe RA, evaluating safety, efficacy, and PK for 48 wks.
- The study demonstrated in meeting 1EPs as AUC (area under the serum concentration–time curve) and Cmax (maximum serum concentration) with biosimiliarity in PK, efficacy, and safety
- ABP 798 (rituximab, biosimilar) is a CD20-directed cytolytic mAb approved for RA, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia (CLL) in the US and EU. In 2011, Amgen and Allergan globally collaborated to develop and commercialize three oncology biosimilar including ABP 798
Click here to read full press release/ article | Ref: Amgen | Image: Calispher