By RTT News, October 08, 2014, 09:23:00 AM EDT <\/p>\n
(RTTNews.com) - Amgen ( AMGN ) announced its Phase 3 study evaluating efficacy and safety of biosimilar candidate ABP 501 compared with Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint. <\/p>\n
The primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment. <\/p>\n
At week 16, the PASI percent improvement from baseline was within the prespecified equivalence margin for ABP 501 compared to adalimumab. Safety and immunogenicity of ABP 501 were comparable to adalimumab. <\/p>\n
ABP 501 is being developed as a biosimilar to adalimumab, an anti-TNF- monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis (PsO), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis. <\/p>\n
\"Results from Amgen's biosimilar Phase 3 plaque psoriasis study met the primary endpoint for efficacy and showed comparable safety and immunogenicity to adalimumab, which further demonstrates the Company's commitment to provide patients with access to high-quality medicines,\" said Sean Harper, M.D., executive vice president of Research and Development at Amgen. <\/p>\n
Amgen said it has six biosimilar molecules in development and expects to launch the portfolio starting in 2017. <\/p>\n
Psoriasis is a non-contagious chronic disease in which the immune system causes skin cells to grow at an accelerated rate. Instead of being shed, skin cells pile up, causing painful and itchy, red, scaly patches. Approximately 125 million people worldwide have psoriasis, and 80 percent of those patients have plaque psoriasis. <\/p>\n
For comments and feedback: contact editorial@rttnews.com<\/a> <\/p>\n http:\/\/www.rttnews.com<\/a> <\/p>\n <\/p>\n See the rest here:<\/p>\n Amgen'biosimilar Phase3 Plaque Psoriasis Study Met Primary Endpoint For Efficacy<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" By RTT News, October 08, 2014, 09:23:00 AM EDT (RTTNews.com) - Amgen ( AMGN ) announced its Phase 3 study evaluating efficacy and safety of biosimilar candidate ABP 501 compared with Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint. The primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment. At week 16, the PASI percent improvement from baseline was within the prespecified equivalence margin for ABP 501 compared to adalimumab. Continue reading