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Amgen Presents Detailed Results From Phase 3 Study Demonstrating Clinical Equivalence Of Biosimilar Candidate ABP 501 With Adalimumab
PipelineReview.com (11/10/15)
A Phase III study demonstrated biosimilarity between Amgen's biosimilar candidate ABP 501 and adalimumab in patients with moderate-to-severe rheumatoid arthritis. The results were presented at the 2015 American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals Annual Meeting in San Francisco. The study consisted of a four-week screening period and a 22-week treatment period. Among participants, 264 were randomized to receive 40 mg ABP 501 subcutaneous injection every two weeks, while 262 were randomized to receive 40 mg subcutaneous adalimumab every two weeks. The study's primary endpoint was achievement of 20 percent or greater improvement in ACR assessment (ACR20) at week 24. At week 24, 74.6 percent of patients in the ABP 501 group and 72.4 percent in the adalimumab group met ACR20 response criteria. The incidence of treatment-emergent adverse events was 50 percent for ABP 501 and 55 percent for adalimumab.
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