Amgen and Allergan Announce Positive Results from Clinical Study of Rituxan Biosimilar Candidate

On August 22, Amgen and Allergan announced positive top-line results from a clinical study (JASMINE) comparing the efficacy and safety of the biosimilar candidate ABP 798 (rituximab) to the reference drug Rituxan® in patients with CD20-positive B-cell non-Hodgkins lymphoma. As we reported in January, ABP 798 was previously found to be bioequivalent to Rituxan® in patients with moderate-to-severe rheumatoid arthritis.

In the JASMINE study, 256 adult patients with non-Hodgkins lymphoma were randomized to receive either ABP 798 or Rituxan® at a dose of 375 mg/m2 intravenously once weekly for four weeks, then again at weeks 12 and 20. After 28 weeks, the overall response rate of patients in the two treatment groups fell within the margin of clinical equivalence, thus meeting the primary endpoint criteria for bioequivalence.

Amgen and Allergan have not yet filed an aBLA for ABP 798, but when they do, they will be the fourth rituximab biosimilar applicant after Celltrion and Teva, Pfizer, and Sandoz.