Business
Amgen And Allergan Announce Positive Top-Line Results From Comparative Clinical Study Of ABP 798, Biosimilar Candidate To Rituxan® (Rituximab)
THOUSAND OAKS, Calif., Aug. 22, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a
About this update from Amgen Inc.
[{"type":"text","content":"THOUSAND OAKS, Calif., Aug. 22, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan® (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin's lymphoma. The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for ABP 798 compared to Rituxan, showing clinical equivalence. Safety and immunogenicity of ABP 798 were comparable to Rituxan. \nThis is the second of two studies intended to support regulatory submissions for ABP 798. The first study was conducted in patients with moderate-to-severe rheumatoid arthritis (RA) and met the primary endpoint of pharmacokinetic similarity. This RA study demonstrated clinical equivalence within the prespecified efficacy margin, and a similar safety and immunogenicity profile.\n\"Today's results with ABP 798 demonstrate another positive development from Amgen's robust pipeline of biosimilar medicines and we look forward to working with regulatory agencies to bring this treatment to patients,\" said David M. Reese, M.D., executive vice president of Research and Development at Amgen. \"We continue to leverage our deep expertise and heritage in biologics across innovative and biosimilar medicines as part of our commitment to providing a range of treatment options for patients with the most serious diseases, including cancer.\"\nABP 798 is being developed as a biosimilar candidate to Rituxan, an anti-CD20 monoclonal antibody that is approved in many regions for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. \nAmgen has a total of 10 biosimilars in its portfolio, including three that are approved in the United States (US).\nAbout the JASMINE Study The JASMINE study was a randomized, double-blind comparative clinical study (study number NCT02747043) that evaluated the efficacy, safety and immunogenicity of ABP 798 compared to rituximab in patients with non-Hodgkin's lymphoma. There were 256 adult patients enrolled and randomized to receive either ABP 798 or rituximab at a dose of 37...