Amgen and Allergan Report Results of ABP 798 (rituximab- biosimilar) in P-I/III (NCT02792699) for Moderate-To-Severe Rheumatoid Arthritis (RA)
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- 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
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